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: July 7, 2014
Last verified: July 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 anti cipated 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00111631     History of Changes
Other Study ID Numbers: BM18106
Study First Received: May 24, 2005
Last Updated: July 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 July 22, 2014