A Study of the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin Naive Type 2 Diabetic Patients Inadequately Controlled With Metformin Plus Sulphonylurea.

Overview[ - collapse ][ - ]

Purpose This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared to insulin glargine in patients with insulin-naive type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea combination therapy. Patients will be randomized to receive taspoglutide (10 mg once weekly, or 10mg once weekly for 4 weeks followed by 20mg once weekly) or insulin glargine (starting dose 10 IU/day) in a ratio of 1:1:1 in addition to continued prestudy metformin treatment. The anticipated time on study treatment is 2+ years, and the target sample size if 500+ individuals.
ConditionDiabetes Mellitus, Type 2
InterventionDrug: taspoglutide
Drug: taspoglutide
Drug: insulin glargine
Drug: metformin
PhasePhase 3
SponsorHoffmann-La Roche
Responsible PartyHoffmann-La Roche
ClinicalTrials.gov IdentifierNCT00755287
First ReceivedSeptember 17, 2008
Last UpdatedApril 7, 2014
Last verifiedApril 2014

Tracking Information[ + expand ][ + ]

First Received DateSeptember 17, 2008
Last Updated DateApril 7, 2014
Start DateNovember 2008
Estimated Primary Completion DateMarch 2011
Current Primary Outcome MeasuresAbsolute change from baseline in HbA1c [Time Frame: 24 weeks] [Designated as safety issue: No]
Current Secondary Outcome Measures
  • Change from baseline in fasting plasma glucose; change from baseline in body weight; responder rates for HbA1c (target <=7.0%, <=6.5%); incidence of hypoglycemia; change from baseline in lipid profile. [Time Frame: 24 weeks] [Designated as safety issue: No]
  • Relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test. [Time Frame: 24 weeks] [Designated as safety issue: No]
  • Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies [Time Frame: Throughout study] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleA Study of the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin Naive Type 2 Diabetic Patients Inadequately Controlled With Metformin Plus Sulphonylurea.
Official TitleA Multicenter, Randomized, Open-label, Active-controlled Study to Compare the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin-naïve Type 2 Diabetic Patients Inadequately Controlled With Metformin and Sulphonylurea Combination Therapy
Brief Summary
This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared
to insulin glargine in patients with insulin-naive type 2 diabetes mellitus inadequately
controlled with metformin and sulphonylurea combination therapy. Patients will be randomized
to receive taspoglutide (10 mg once weekly, or 10mg once weekly for 4 weeks followed by 20mg
once weekly) or insulin glargine (starting dose 10 IU/day) in a ratio of 1:1:1 in addition
to continued prestudy metformin treatment. The anticipated time on study treatment is 2+
years, and the target sample size if 500+ individuals.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionDiabetes Mellitus, Type 2
InterventionDrug: taspoglutide
10 mg once weekly
Drug: taspoglutide
20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly)
Drug: insulin glargine
starting dose 10 IU daily
Drug: metformin
As prescribed
Study Arm (s)
  • Experimental: 1
  • Experimental: 2
  • Active Comparator: 3

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment1072
Estimated Completion DateMarch 2011
Estimated Primary Completion DateMarch 2011
Eligibility Criteria
Inclusion Criteria:

- adult patients, 18-75 years of age;

- type 2 diabetes treated with a stable dose of metformin and sulphonylurea for at
least 12 weeks;

- C-peptide (fasting) >=1.0ng/mL;

- HbA1c >=7.0% and <=10.0% at screening;

- BMI >=25 (>23 for Asians) and <=45kg/m2 at screening;

- stable weight +-5% for at least 12 weeks prior to screening.

Exclusion Criteria:

- history of type 1 diabetes mellitus or acute metabolic diabetic complications such as
ketoacidosis or hyperosmolar coma in the previous 6 months;

- evidence of clinically significant diabetic complications;

- symptomatic poorly controlled diabetes;

- clinically symptomatic gastrointestinal disease;

- myocardial infarction, coronary artery bypass surgery, post-transplantation
cardiomyopathy or stroke within the previous 6 months;

- known hemoglobinopathy or chronic anemia.
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States, Australia, Austria, Belgium, Brazil, Canada, Czech Republic, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Italy, Korea, Republic of, Mexico, New Zealand, Peru, Poland, Portugal, Russian Federation, Serbia, Spain, Thailand, United Kingdom

Administrative Information[ + expand ][ + ]

NCT Number NCT00755287
Other Study ID NumbersBC20965
Has Data Monitoring CommitteeNot Provided
Information Provided ByHoffmann-La Roche
Study SponsorHoffmann-La Roche
CollaboratorsNot Provided
Investigators Study Director: Clinical Trials Hoffmann-La Roche
Verification DateApril 2014

Locations[ + expand ][ + ]

United States, Arizona
Phoenix, Arizona, United States, 85032
United States, Arkansas
Searcy, Arkansas, United States, 72143
United States, California
Concord, California, United States, 94520
United States, California
Huntington Beach, California, United States, 92648
United States, California
Los Angeles, California, United States, 90025
United States, California
Los Angeles, California, United States, 90015
United States, California
Los Gatos, California, United States, 95032
United States, California
Roseville, California, United States, 95661
United States, California
San Diego, California, United States, 92109
United States, California
Santa Ana, California, United States, 92705
United States, California
Westlake Village, California, United States, 91361
United States, District of Columbia
Washington, District of Columbia, United States, 20010
United States, Florida
Green Cove Springs, Florida, United States, 32043
United States, Florida
Hialeah, Florida, United States, 33013
United States, Florida
Jacksonville, Florida, United States, 32204
United States, Florida
Jacksonville, Florida, United States, 32216
United States, Florida
Ormond Beach, Florida, United States, 32174
United States, Florida
Oviedo, Florida, United States, 32765
United States, Florida
Palm Harbor, Florida, United States, 34684
United States, Florida
Trinity, Florida, United States, 34655
United States, Florida
Zephyrhills, Florida, United States, 33542
United States, Georgia
Atlanta, Georgia, United States, 30338
United States, Illinois
Quincy, Illinois, United States, 62301
United States, Illinois
Springfield, Illinois, United States, 62704-1433
United States, Indiana
Avon, Indiana, United States, 46123
United States, Indiana
Indianapolis, Indiana, United States, 46260
United States, Kansas
Arkansas City, Kansas, United States, 67005
United States, Kentucky
Crestview Hills, Kentucky, United States, 41017
United States, Louisiana
Metairie, Louisiana, United States, 70006
United States, Louisiana
Sunset, Louisiana, United States, 70584
United States, Maine
Portland, Maine, United States, 04101
United States, Maryland
North East, Maryland, United States, 21901
United States, Massachusetts
Worchester, Massachusetts, United States, 01605
United States, Michigan
St. Claire Shores, Michigan, United States, 48081
United States, Mississippi
Jackson, Mississippi, United States, 39216
United States, Mississippi
Picayune, Mississippi, United States, 39466
United States, Missouri
Springfield, Missouri, United States, 65807
United States, Nebraska
Grand Island, Nebraska, United States, 68803
United States, Nebraska
Omaha, Nebraska, United States, 68131
United States, Nebraska
Omaha, Nebraska, United States, 68105
United States, Nevada
Henderson, Nevada, United States, 89014
United States, New Jersey
Blackwood, New Jersey, United States, 08012
United States, New Jersey
Cherry Hill, New Jersey, United States, 08002
United States, New Jersey
Moorestown, New Jersey, United States, 08057
United States, New Jersey
Toms River, New Jersey, United States, 08753
United States, New Jersey
Toms River, New Jersey, United States, 08755
United States, New York
Albany, New York, United States, 12206-1098
United States, New York
Flushing, New York, United States, 11365
United States, New York
Mineola, New York, United States, 11501
United States, North Carolina
Asheville, North Carolina, United States, 28803
United States, North Carolina
Harrisburg, North Carolina, United States, 28075
United States, North Dakota
Fargo, North Dakota, United States, 58103
United States, Ohio
Centerville, Ohio, United States, 45459
United States, Ohio
Cincinnati, Ohio, United States, 45242
United States, Ohio
Genoa, Ohio, United States, 43430-1143
United States, Ohio
Toledo, Ohio, United States, 43606
United States, Pennsylvania
Altoona, Pennsylvania, United States, 16602
United States, Pennsylvania
Bensalem, Pennsylvania, United States, 19020
United States, Pennsylvania
Feasterville, Pennsylvania, United States, 19053
United States, Pennsylvania
Harrisburg, Pennsylvania, United States, 17112
United States, Pennsylvania
Jefferson Hills, Pennsylvania, United States, 15025
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19146
United States, Pennsylvania
Scranton, Pennsylvania, United States, 18510
United States, Pennsylvania
Tipton, Pennsylvania, United States, 16684
United States, South Carolina
Orangeburg, South Carolina, United States, 29115
United States, Tennessee
Johnson City, Tennessee, United States, 37604
United States, Texas
Dallas, Texas, United States, 75246
United States, Texas
Dallas, Texas, United States, 75390
United States, Texas
Dallas, Texas, United States, 75230
United States, Texas
Houston, Texas, United States, 77030
United States, Texas
Houston, Texas, United States, 77024
United States, Virginia
Richmond, Virginia, United States, 23249
United States, Wisconsin
Waukesha, Wisconsin, United States, 53189
Australia, New South Wales
St. Leonards, New South Wales, Australia, 2065
Australia, New South Wales
Wollongong, New South Wales, Australia, 2500
Australia, Queensland
Freemantle, Queensland, Australia, 6959
Austria
Graz, Austria, 8036
Austria
Salzburg, Austria, 5020
Austria
Wien, Austria, 1030
Austria
Wien, Austria, 1130
Austria
Wien, Austria, 1080
Belgium
Arlon, Belgium, 6700
Belgium
Bonheiden, Belgium, 2820
Belgium
Leuven, Belgium, 3000
Belgium
Liege, Belgium, 4000
Brazil, PE
Recife, PE, Brazil, 52051-380
Brazil, PR
Campina Grande do Sul, PR, Brazil, 83430-000
Brazil, PR
Curitiba, PR, Brazil, 80030-110
Brazil, RS
Porto Alegre, RS, Brazil, 90035-170
Brazil, SP
Sao Paulo, SP, Brazil, 04022-001
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 1L8
Canada, Ontario
Hamilton, Ontario, Canada, L8S 4J9
Canada, Ontario
London, Ontario, Canada, N6A 5R8
Canada, Ontario
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
Pointe-Claire, Quebec, Canada, H9R 4S3
Canada, Quebec
Sherbrooke, Quebec, Canada, J1G 5K2
Czech Republic
Brno, Czech Republic, 625 00
Czech Republic
Havirov, Czech Republic, 76301
Czech Republic
Plzen, Czech Republic, 301 00
Czech Republic
Praha, Czech Republic, 180 00
Czech Republic
Trutnov, Czech Republic, 541 01
Finland
Helsinki, Finland, 00150
Finland
Jyvaeskylae, Finland, 40100
Finland
Tampere, Finland, 33100
France
Avignon, France, 84902
France
Besancon, France, 25030
France
Bois Guillaume, France, 76233
France
Brest, France, 29609
France
Corbeil Essonnes, France, 91106
France
La Rochelle, France, 17019
France
Marseille, France, 13015
France
Marseille, France, 13385
France
Montpellier, France, 34295
France
Nimes, France, 30029
France
Paris, France, 75908
France
Paris, France, 75877
France
Paris, France, 75651
France
Strasbourg, France, 67091
France
Venissieux, France, 69200
Germany
Bad Lauterberg, Germany, 37431
Germany
Berlin, Germany, 10115
Germany
Bochum, Germany, 44869
Germany
Bosenheim, Germany, 55545
Germany
Dortmund, Germany, 44137
Germany
Falkensee, Germany, 14612
Germany
Freiburg, Germany, 79106
Germany
Mainz, Germany, 55116
Germany
Offenbach a.M., Germany, 63065
Germany
Reichenbach, Germany, 08468
Germany
Würzburg, Germany, 97072
Greece
Athens, Greece, 10552
Greece
Larissa, Greece, 41110
Greece
Thessaloniki, Greece, 56429
Guatemala
Guatemala, Guatemala, 01010
Hong Kong
Hong Kong, Hong Kong
Hungary
Balatonfuered, Hungary, 8230
Hungary
Budapest, Hungary, 1045
Hungary
Szekszard, Hungary, 7100
Italy, Campania
Napoli, Campania, Italy, 80100
Italy, Lazio
Roma, Lazio, Italy, 00157
Italy, Lombardia
Codogno, Lombardia, Italy, 26845
Italy, Lombardia
Milano, Lombardia, Italy, 20132
Italy, Lombardia
Milano, Lombardia, Italy, 20142
Italy, Piemonte
Torino, Piemonte, Italy, 10126
Korea, Republic of
Daegu, Korea, Republic of, 700-721
Korea, Republic of
Incheon, Korea, Republic of
Korea, Republic of
Seoul, Korea, Republic of, 137-040
Mexico
Aguascalientes, Mexico, 20127
Mexico
Cuernavaca, Mexico, 62250
Mexico
Monterrey, Mexico, 64410
Mexico
Tampico, Mexico, 89000
New Zealand
Auckland, New Zealand
New Zealand
Auckland, New Zealand, 1640
Peru
Arequipa, Peru, Cercado
Peru
Lima, Peru, Lima 33
Peru
Lima, Peru, Lima 1
Peru
Trujillo, Peru, 13011
Poland
Grodzisk Mazowiecki, Poland, 05-825
Poland
Kamieniec Zabkowicki, Poland, 57-230
Poland
Lodz, Poland, 93-338
Poland
Rzeszow, Poland, 35-073
Poland
Sobótka, Poland, 55-050
Poland
Szczecin, Poland, 71-455
Poland
Wroclaw, Poland, 51-124
Portugal
Coimbra, Portugal, 3000-075
Portugal
Lisboa, Portugal, 1250-203
Portugal
Lisboa, Portugal, 1349-019
Puerto Rico
Guyanabo, San Juan, Puerto Rico, 00920
Puerto Rico
Levittown, Puerto Rico, 00950
Puerto Rico
Orocovis, Puerto Rico, 00720
Puerto Rico
Ponce, Puerto Rico, 00717-322
Puerto Rico
San Juan, Puerto Rico, 00926-2832
Puerto Rico
Trujillo Alto, Puerto Rico, 00976
Russian Federation
Barnaul, Russian Federation, 656024
Russian Federation
Chelyabinsk, Russian Federation, 454136
Russian Federation
Moscow, Russian Federation, 117049
Russian Federation
Moscow, Russian Federation, 125299
Russian Federation
Moscow, Russian Federation, 129110
Russian Federation
Nizhny Novgorod, Russian Federation, 603126
Russian Federation
Novosibirsk, Russian Federation, 630047
Russian Federation
Omsk, Russian Federation, 644021
Russian Federation
Saint-Petersburg, Russian Federation, 197022
Russian Federation
St Petersburg, Russian Federation, 195213
Russian Federation
St-Petersburg, Russian Federation, 194291
Russian Federation
St. Petersburg, Russian Federation, 193012
Russian Federation
St. Petersburg, Russian Federation, 194354
Russian Federation
Tomsk, Russian Federation, 643050
Serbia
Belgrade, Serbia, 11000
Serbia
Kragujevac, Serbia, 34000
Serbia
Nis, Serbia, 18000
Serbia
Novi Sad, Serbia, 21000
Spain, Madrid
Pozuelo de alarcon, Madrid, Spain, 28223
Spain, Valencia
Alzira, Valencia, Spain, 46600
Spain
Almeria, Spain, 04001
Spain
Barcelona, Spain, 08025
Spain
Granada, Spain, 18012
Spain
Sevilla, Spain, 41013
Spain
Sevilla, Spain, 41010
Spain
Valencia, Spain, 46014
Spain
Valencia, Spain, 46010
Spain
Valladolid, Spain, 47005
Thailand
Bangkok, Thailand, 10330
Thailand
Bangkok, Thailand, 10400
United Kingdom
Atherstone, United Kingdom, CV9 1EU
United Kingdom
Chesterfield, United Kingdom, S40 4TF
United Kingdom
Dumfries, United Kingdom, DG1 4AP
United Kingdom
Liverpool, United Kingdom, L9 7AL
United Kingdom
Sheffield, United Kingdom, S18 1RU
United Kingdom
Trowbridge, United Kingdom, BA14 8QA