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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00111631
Recruitment Status : Completed
First Posted : May 25, 2005
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: DPP-IV Inhibitor Drug: Metformin Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 218 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A 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
Study Start Date : May 2005
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Metformin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: DPP-IV Inhibitor
Escalating doses po bid
Drug: Metformin
As prescribed
Experimental: 2 Drug: DPP-IV Inhibitor
Escalating doses po bid
Drug: Metformin
As prescribed
Experimental: 3 Drug: DPP-IV Inhibitor
Escalating doses po bid
Drug: Metformin
As prescribed
Placebo Comparator: 4 Drug: Metformin
As prescribed
Drug: Placebo
po bid

Primary Outcome Measures :
  1. Absolute change from baseline in HbAlc\n [ Time Frame: Week 16 ]

Secondary Outcome Measures :
  1. Absolute change in FPG and absolute/relative change in insulin sensitivity, beta-cell-function, and lipid profile, response rate\n [ Time Frame: Week 16 ]
  2. AEs, vital signs, laboratory tests, body weight, waist/hip ratio, ECG\n [ Time Frame: Throughout study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00111631

  Hide Study Locations
United States, California
Concord, California, United States, 94520
Salinas, California, United States, 93901
San Diego, California, United States, 92161
United States, Colorado
Boulder, Colorado, United States, 80304
United States, Delaware
Newark, Delaware, United States, 19713
Wilmington, Delaware, United States, 19085
United States, Florida
Clearwater, Florida, United States, 33765
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
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
Warminster, Pennsylvania, United States, 18974
United States, Texas
Dallas, Texas, United States, 75246
Midland, Texas, United States, 79707
San Antonio, Texas, United States, 78229
Adelaide, Australia, 5000
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
Toronto, Ontario, Canada, M5C 2T2
Bad Lauterberg, Germany, 37431
Berlin, Germany, 10115
Dresden, Germany, 01307
Görlitz, Germany, 02826
Mainz, Germany, 55116
Neuss, Germany, 41460
Ancona, Italy, 60131
Firenze, Italy, 50100
Napoli, Italy, 80100
Udine, Italy, 33100
Puerto Rico
Ponce, Puerto Rico, 00716
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT00111631     History of Changes
Other Study ID Numbers: BM18106
First Posted: May 25, 2005    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs