A Study of Taspoglutide Versus Sitagliptin for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin.

Overview[ - collapse ][ - ]

Purpose This 4 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to sitagliptin and placebo in patients with type 2 diabetes mellitus inadequately controlled with metformin. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly), sitagliptin 100mg once daily or placebo, in a ratio of 2:2:2:1, in addition to their continued prestudy metformin treatment. After 24 weeks of treatment, patients on active treatment will continue on the same treatment and patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly). The anticipated time on study treatment is 2+ years, and the target sample size is 500+ individuals.
ConditionDiabetes Mellitus, Type 2
InterventionDrug: taspoglutide
Drug: taspoglutide
Drug: sitagliptin
Drug: placebo
Drug: metformin
Drug: placebo
PhasePhase 3
SponsorHoffmann-La Roche
Responsible PartyHoffmann-La Roche
ClinicalTrials.gov IdentifierNCT00754988
First ReceivedSeptember 17, 2008
Last UpdatedOctober 17, 2011
Last verifiedOctober 2011

Tracking Information[ + expand ][ + ]

First Received DateSeptember 17, 2008
Last Updated DateOctober 17, 2011
Start DateOctober 2008
Estimated Primary Completion DateNot Provided
Current Primary Outcome MeasuresMean changes 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%); responder rates for body weight; change from baseline in lipid profile; beta cell function. [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 Taspoglutide Versus Sitagliptin for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin.
Official TitleA Multicenter, Randomized, Double-dummy, Placebo and Active-controlled Study to Assess the Safety, Tolerability and Effect of Taspoglutide on Glycemic Control Compared to Sitagliptin and Placebo in Patients With Type II Diabetes Mellitus Inadequately Controlled With Metformin.
Brief Summary
This 4 arm study will assess the efficacy, safety and tolerability of taspoglutide compared
to sitagliptin and placebo in patients with type 2 diabetes mellitus inadequately controlled
with metformin. Patients will be randomized to receive taspoglutide (10mg once weekly or
10mg once weekly for 4 weeks followed by 20mg once weekly), sitagliptin 100mg once daily or
placebo, in a ratio of 2:2:2:1, in addition to their continued prestudy metformin treatment.
After 24 weeks of treatment, patients on active treatment will continue on the same
treatment and patients on placebo will be switched to taspoglutide 10mg once weekly or
taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly). The
anticipated time on study treatment is 2+ years, and the target sample size is 500+
individuals.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
ConditionDiabetes Mellitus, Type 2
InterventionDrug: taspoglutide
10mg sc once weekly
Drug: taspoglutide
20mg sc once weekly (after 4 weeks of taspoglutide 10mg sc once weekly)
Drug: sitagliptin
100mg po once daily
Drug: placebo
sc once weekly
Drug: metformin
As prescribed
Drug: placebo
po once daily
Study Arm (s)
  • Experimental: 1
  • Experimental: 2
  • Active Comparator: 3
  • Placebo Comparator: 4

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment666
Estimated Completion DateNot Provided
Estimated Primary Completion DateNot Provided
Eligibility Criteria
Inclusion Criteria:

- adult patients, 18-75 years of age;

- type 2 diabetes receiving metformin (>=1500mg/day) for at least 12 weeks;

- 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;

- 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, Argentina, Australia, Canada, France, Germany, Greece, Korea, Republic of, Mexico, Norway, Peru, Poland, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom

Administrative Information[ + expand ][ + ]

NCT Number NCT00754988
Other Study ID NumbersBC21713
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 DateOctober 2011

Locations[ + expand ][ + ]

United States, Alabama
Birmingham, Alabama, United States, 35233
United States, Alabama
Huntsville, Alabama, United States, 35802
United States, Alabama
Tallassee, Alabama, United States, 36078
United States, Arizona
Scottsdale, Arizona, United States, 85254
United States, Arkansas
Little Rock, Arkansas, United States, 72205
United States, California
Huntington Beach, California, United States, 92646
United States, California
La Jolla, California, United States, 92037
United States, California
Los Angeles, California, United States, 90017
United States, California
Roseville, California, United States, 95661
United States, California
San Francisco, California, United States, 94109
United States, California
Tacoma, California, United States, 98405
United States, Colorado
Colorado Springs, Colorado, United States, 80904
United States, Connecticut
New London, Connecticut, United States, 06320
United States, District of Columbia
Manati, District of Columbia, United States, 00674
United States, Florida
Daytona Beach, Florida, United States, 32117
United States, Florida
Hialeah, Florida, United States, 33012
United States, Florida
Jacksonville, Florida, United States, 32205
United States, Florida
Miami, Florida, United States, 33186
United States, Florida
Panama City, Florida, United States, 32401
United States, Florida
St Petersburg, Florida, United States, 33606
United States, Georgia
Augusta, Georgia, United States, 30904
United States, Georgia
Conyers, Georgia, United States, 30094
United States, Georgia
Snellville, Georgia, United States, 30029
United States, Hawaii
Honolulu, Hawaii, United States, 96813
United States, Indiana
Indianapolis, Indiana, United States, 46229
United States, Indiana
Indianapolis, Indiana, United States, 46254
United States, Indiana
Lafayette, Indiana, United States, 47904
United States, Indiana
South Bend, Indiana, United States, 46628
United States, Maryland
Baltimore, Maryland, United States, 21229
United States, Massachusetts
Brockton, Massachusetts, United States, 02301
United States, Michigan
Cadillac, Michigan, United States, 49601
United States, Minnesota
Brooklyn Center, Minnesota, United States, 55430
United States, Minnesota
Minneapolis, Minnesota, United States, 55416
United States, Missouri
St. Peters, Missouri, United States, 63376
United States, New York
Fulton, New York, United States, 13069
United States, New York
Hudson, New York, United States, 12534
United States, New York
Rochester, New York, United States, 14609
United States, North Carolina
Charlotte, North Carolina, United States, 28211
United States, North Carolina
Raleigh, North Carolina, United States, 27609
United States, North Carolina
Shelby, North Carolina, United States, 28150
United States, North Carolina
Statesville, North Carolina, United States, 28625
United States, North Carolina
Winston-salem, North Carolina, United States, 27103
United States, Ohio
Columbus, Ohio, United States, 43213
United States, Ohio
Delaware, Ohio, United States, 43015
United States, Ohio
Marion, Ohio, United States, 43302
United States, Oregon
Corvallis, Oregon, United States, 97330
United States, Oregon
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Aliquippa, Pennsylvania, United States, 15001
United States, Pennsylvania
Beaver, Pennsylvania, United States, 15009
United States, Pennsylvania
Erie, Pennsylvania, United States, 16508
United States, Pennsylvania
Reading, Pennsylvania, United States, 17601
United States, Pennsylvania
Reading, Pennsylvania, United States, 19606
United States, Pennsylvania
Shippensburg, Pennsylvania, United States, 17257
United States, Pennsylvania
Warminster, Pennsylvania, United States, 18974
United States, South Carolina
Anderson, South Carolina, United States, 29621
United States, Tennessee
Kingsport, Tennessee, United States, 37660
United States, Texas
Dallas, Texas, United States, 75230
United States, Texas
Houston, Texas, United States, 77030
United States, Vermont
South Burlington, Vermont, United States, 05403
United States, Virginia
Hampton, Virginia, United States, 23666
United States, Virginia
Norfolk, Virginia, United States, 23502
United States, Virginia
Richmond, Virginia, United States, 23294
United States, Virginia
Richmond, Virginia, United States, 23249
United States, Washington
Federal Way, Washington, United States, 98003
Argentina
Buenos Aires, Argentina, C1012
Argentina
Buenos Aires, Argentina, C1213AAH
Argentina
Mar Del Plata, Argentina, B7600GNY
Australia
Adelaide, Australia, 5000
Australia
Freemantle, Australia, 6959
Canada, Ontario
London, Ontario, Canada, NGA 4V2
Canada, Ontario
Thornhill, Ontario, Canada, L4J 8L7
Canada, Ontario
Toronto, Ontario, Canada, M9W 4L6
Canada
Montreal, Canada, H2W 1T8
Canada
Pointe-claire, Canada, H9R 4S3
France
Bondy, France, 93143
France
Nantes, France, 44093
France
Poitiers, France, 86021
France
Rennes, France, 35203
France
Saint-mandé, France, 94160
Germany
Berlin, Germany, 10115
Germany
Dormagen, Germany, 41539
Germany
Dresden, Germany, 01307
Germany
Kiel Kronshagen, Germany, 24119
Germany
München, Germany, 80336
Germany
Sulzbach-rosenberg, Germany, 92237
Germany
Villingen-schwenningen, Germany, 78048
Greece
Larissa, Greece, 41110
Korea, Republic of
Gyeonggi-do, Korea, Republic of
Korea, Republic of
Kangwon-do, Korea, Republic of, 220-701
Korea, Republic of
Seoul, Korea, Republic of, 152-703
Korea, Republic of
Seoul, Korea, Republic of
Korea, Republic of
Suwon City, Korea, Republic of, 443-721
Mexico
Cuernavaca, Mexico, 62250
Mexico
Hermosillo, Mexico, 83200
Mexico
Jalisco, Mexico, 44690
Mexico
Mexico City, Mexico, 11520
Mexico
Mexico City, Mexico, 06700
Mexico
Monterrey, Mexico, 64000
Mexico
Pachuca, Mexico, 42086
Norway
Elverum, Norway, 2401
Norway
Oslo, Norway, 0176
Norway
Oslo, Norway, 0407
Norway
Oslo, Norway, 0027
Peru
Lima, Peru, Lima 33
Peru
Lima, Peru, Lima 9
Poland
Bialystok, Poland, 15-445
Poland
Gdansk, Poland, 80-858
Poland
Kamieniec Zabkowicki, Poland, 57-230
Poland
Rzeszow, Poland, 35-073
Poland
Skierniewice, Poland, 96-100
Poland
Sobótka, Poland, 55-050
Poland
Wroclaw, Poland, 51-124
Puerto Rico
Caguas, Puerto Rico, 00725
Puerto Rico
Carolina, Puerto Rico, 00983
Romania
Bucuresti, Romania, 020359
Romania
Buzau, Romania, 120203
Romania
Cluj-napoca, Romania, 400006
Romania
Ploiesti, Romania, 100163
Romania
Ploiesti, Romania, 100342
Slovakia
Levice, Slovakia, 93405
Slovakia
Presov, Slovakia, 080 01
Slovakia
Samorin, Slovakia, 931 01
Slovakia
Trebisov, Slovakia, 07501
Slovakia
Trencin, Slovakia, 911 01
South Africa
Pretoria, South Africa, 0002
South Africa
Somerset West, South Africa, 7130
Spain
Almeria, Spain, 04001
Spain
Bacarot Alicant, Spain, 03114
Spain
Sevilla, Spain, 41010
Spain
Valencia, Spain, 46014
Sweden
Ljungby, Sweden, 34182
Sweden
Stockholm, Sweden, 14186
Sweden
Örebro, Sweden, 701 85
Switzerland
Basel, Switzerland, 4051
Switzerland
Geneve, Switzerland, 1211
Switzerland
Zürich, Switzerland, 8063
Taiwan
Taichung, Taiwan, 407
Taiwan
Taipei, Taiwan, 114
Taiwan
Taipei, Taiwan, 220
Taiwan
Taoyuan County, Taiwan, 333
Thailand
Bangkok, Thailand, 10330
Thailand
Songkla, Thailand, 90112
Turkey
Istanbul, Turkey, 34390
United Kingdom
Bexhill on Sea, United Kingdom, TN39 4SP
United Kingdom
Crawley, United Kingdom, RH10 7DX
United Kingdom
Glasgow, United Kingdom, G46 8NY
United Kingdom
Hinckley, United Kingdom, LE10 2SE
United Kingdom
Reading, United Kingdom, RG7 3SQ