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

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00111631
First received: May 24, 2005
Last updated: May 13, 2009
Last verified: May 2009
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Absolute change from baseline in HbAlc [ 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 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • AEs, vital signs, laboratory tests, body weight, waist/hip ratio, ECG [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 218
Study Completion Date: October 2006
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

  Show 37 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00111631     History of Changes
Other Study ID Numbers: BM18106
Study First Received: May 24, 2005
Last Updated: May 13, 2009
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 May 19, 2013