A Study of DPP-IV Inhibitor in Patients With Type 2 Diabetes

Overview[ - collapse ][ - ]

Purpose This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor in patients with type 2 diabetes receiving a stable dose of metformin. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
ConditionDiabetes Mellitus, Type 2
InterventionDrug: DPP-IV Inhibitor
Drug: Placebo
Drug: Metformin
PhasePhase 2
SponsorHoffmann-La Roche
Responsible PartyHoffmann-La Roche
ClinicalTrials.gov IdentifierNCT00111631
First ReceivedMay 24, 2005
Last UpdatedApril 7, 2014
Last verifiedApril 2014

Tracking Information[ + expand ][ + ]

First Received DateMay 24, 2005
Last Updated DateApril 7, 2014
Start DateMay 2005
Estimated Primary Completion DateOctober 2006
Current Primary Outcome MeasuresAbsolute change from baseline in HbAlc\n [Time Frame: Week 16] [Designated as safety issue: No]
Current Secondary Outcome Measures
  • Absolute change in FPG and absolute/relative change in insulin sensitivity, beta-cell-function, and lipid profile, response rate\n [Time Frame: Week 16] [Designated as safety issue: No]
  • AEs, vital signs, laboratory tests, body weight, waist/hip ratio, ECG\n [Time Frame: Throughout study] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleA Study of DPP-IV Inhibitor in Patients With Type 2 Diabetes
Official TitleA Randomized, Double-blind Study of the Effect of the DPP-IV Inhibitor on HbA1c and Safety in Patients With Type 2 Diabetes Treated With a Stable Dose of Metformin
Brief Summary
This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor in patients
with type 2 diabetes receiving a stable dose of metformin. The anticipated time on study
treatment is 3-12 months and the target sample size is 100-500 individuals.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 2
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: DPP-IV Inhibitor
Escalating doses po bid
Drug: Placebo
po bid
Drug: Metformin
As prescribed
Study Arm (s)
  • Experimental: 1
  • Experimental: 2
  • Experimental: 3
  • Placebo Comparator: 4

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment218
Estimated Completion DateOctober 2006
Estimated Primary Completion DateOctober 2006
Eligibility Criteria
Inclusion Criteria:

- adult patients 18-75 years of age;

- type 2 diabetes;

- stable metformin therapy for >=3 months before screening.

Exclusion Criteria:

- women who are pregnant, breast-feeding, or not using an adequate contraceptive
method;

- type 1 diabetes;

- any anti-hyperglycemic medication other than metformin in the last 3 months.
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States, Australia, Canada, Germany, Italy

Administrative Information[ + expand ][ + ]

NCT Number NCT00111631
Other Study ID NumbersBM18106
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, California
Concord, California, United States, 94520
United States, California
Salinas, California, United States, 93901
United States, California
San Diego, California, United States, 92161
United States, Colorado
Boulder, Colorado, United States, 80304
United States, Delaware
Newark, Delaware, United States, 19713
United States, Delaware
Wilmington, Delaware, United States, 19085
United States, Florida
Clearwater, Florida, United States, 33765
United States, Florida
Miami, Florida, United States, 33156
United States, Illinois
Chicago, Illinois, United States, 60607
United States, Michigan
Detroit, Michigan, United States, 48202-2689
United States, New York
Buffalo, New York, United States, 14209
United States, New York
Rochester, New York, United States, 14609
United States, North Carolina
Durham, North Carolina, United States, 27713
United States, Ohio
Mogadore, Ohio, United States, 44260
United States, Oregon
Portland, Oregon, United States, 97239
United States, Pennsylvania
Connellsville, Pennsylvania, United States, 15425
United States, Pennsylvania
Warminster, Pennsylvania, United States, 18974
United States, Texas
Dallas, Texas, United States, 75246
United States, Texas
Midland, Texas, United States, 79707
United States, Texas
San Antonio, Texas, United States, 78229
Australia
Adelaide, Australia, 5000
Australia
Sydney, Australia, 2050
Canada, Manitoba
Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
London, Ontario, Canada, NGA 4V2
Canada, Ontario
Toronto, Ontario, Canada, M5C 2T2
Germany
Bad Lauterberg, Germany, 37431
Germany
Berlin, Germany, 10115
Germany
Dresden, Germany, 01307
Germany
Görlitz, Germany, 02826
Germany
Mainz, Germany, 55116
Germany
Neuss, Germany, 41460
Italy
Ancona, Italy, 60131
Italy
Firenze, Italy, 50100
Italy
Napoli, Italy, 80100
Italy
Udine, Italy, 33100
Puerto Rico
Ponce, Puerto Rico, 00716