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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00111631
First received: May 24, 2005
Last updated: April 7, 2014
Last verified: April 2014
  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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: DPP-IV Inhibitor
Drug: Placebo
Drug: Metformin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Absolute change from baseline in HbAlc\n [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

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 ]

Enrollment: 218
Study Start Date: May 2005
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Placebo
po bid
Drug: Metformin
As prescribed

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00111631

  Hide Study Locations
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
Australia
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
Germany
Bad Lauterberg, Germany, 37431
Berlin, Germany, 10115
Dresden, Germany, 01307
Görlitz, Germany, 02826
Mainz, Germany, 55116
Neuss, Germany, 41460
Italy
Ancona, Italy, 60131
Firenze, Italy, 50100
Napoli, Italy, 80100
Udine, Italy, 33100
Puerto Rico
Ponce, Puerto Rico, 00716
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00111631     History of Changes
Other Study ID Numbers: BM18106
Study First Received: May 24, 2005
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014