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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.
ClinicalTrials.gov Identifier: NCT00111631
Recruitment Status : Completed
First Posted : May 25, 2005
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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 Design

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
Primary Completion Date : October 2006
Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

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

Arms and Interventions

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


Outcome Measures

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 ]

Eligibility Criteria

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
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

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 ClinicalTrials.gov identifier (NCT number): NCT00111631


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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov 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
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs