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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus Type 2
• Intervention / Treatment: Drug: Placebo; Drug: Metformin; Drug: DPP-IV Inhibitor

• Study Type: Interventional
• Enrollment (Actual): 218
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia, 5000
  • Sydney, Australia, 2050
• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 3P4
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
  • 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
• United States
  • California
    • Concord, California, United States, 94520
    • Salinas, California, United States, 93901
    • San Diego, California, United States, 92161
  • Colorado
    • Boulder, Colorado, United States, 80304
  • Delaware
    • Newark, Delaware, United States, 19713
    • Wilmington, Delaware, United States, 19085
  • Florida
    • Clearwater, Florida, United States, 33765
    • Miami, Florida, United States, 33156
  • Illinois
    • Chicago, Illinois, United States, 60607
  • Michigan
    • Detroit, Michigan, United States, 48202-2689
  • New York
    • Buffalo, New York, United States, 14209
    • Rochester, New York, United States, 14609
  • North Carolina
    • Durham, North Carolina, United States, 27713
  • Ohio
    • Mogadore, Ohio, United States, 44260
  • Oregon
    • Portland, Oregon, United States, 97239
  • Pennsylvania
    • Connellsville, Pennsylvania, United States, 15425
    • Warminster, Pennsylvania, United States, 18974
  • Texas
    • Dallas, Texas, United States, 75246
    • Midland, Texas, United States, 79707
    • San Antonio, Texas, United States, 78229

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Absolute change from baseline in HbAlc\n	Week 16

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: May 1, 2005
• Primary Completion (Actual): October 1, 2006
• Study Completion (Actual): October 1, 2006

Study Registration Dates

• First Submitted: May 24, 2005
• First Submitted That Met QC Criteria: May 24, 2005
• First Posted (Estimate): May 25, 2005

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Metformin; Dipeptidyl-Peptidase IV Inhibitors
• Other Study ID Numbers: BM18106