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

November 1, 2016 updated by: Hoffmann-La Roche

A Randomized, Double-blind Study of the Effect of the DPP-IV Inhibitor on HbA1c and Safety in Patients With Type 2 Diabetes

This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor compared to placebo in patients with type 2 diabetes. The anticipated time on study treatment is < 3 months and the target sample size is 100-500 individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

291

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Ruse, Bulgaria, 7002
      • Sofia, Bulgaria, 1233
      • Sofia, Bulgaria, 1606
  • Costa Rica
      • San Jose, Costa Rica, 755-1000
  • Estonia
      • Tartu, Estonia, 50406
      • Tartu, Estonia, 51014
  • Latvia
      • Ogre, Latvia, 5001
      • Riga, Latvia, 1002
  • Lithuania
      • Klaipeda, Lithuania, 92304
      • Vilnius, Lithuania, 08661
  • Mexico
      • Chihuahua, Mexico, 31238
      • Guadalajara, Mexico, 44340
      • Guadalajara, Mexico, 44650
      • Mexico City, Mexico, 14000
      • Mexico City, Mexico, 06726
      • Monterrey, Mexico, 64460
      • Pachuca, Mexico, 42086
  • Puerto Rico
      • Ponce, Puerto Rico, 00716
  • Romania
      • Bucharest, Romania, 020475
      • Cluj-napoca, Romania, 400006
      • Ploiesti, Romania, 100163
      • Tirgu-mures, Romania, 540011
  • United States
    • California
      • Salinas, California, United States, 93901
    • Florida
      • Clearwater, Florida, United States, 33765
      • Hialeah, Florida, United States, 33013
      • Pembroke Pines, Florida, United States, 33029
    • Georgia
      • Blue Ridge, Georgia, United States, 30513
    • Illinois
      • Aurora, Illinois, United States, 60504
    • Maryland
      • Elkton, Maryland, United States, 21921
      • Oxon Hill, Maryland, United States, 20745
    • Michigan
      • Troy, Michigan, United States, 48098
    • Nevada
      • Pahrump, Nevada, United States, 89048
    • Ohio
      • Cincinnati, Ohio, United States, 45224
    • Oregon
      • Portland, Oregon, United States, 97239
    • Pennsylvania
      • Warminster, Pennsylvania, United States, 18974
    • Texas
      • Dallas, Texas, United States, 75246
      • Midland, Texas, United States, 79707
      • San Antonio, Texas, United States, 78229
    • Virginia
      • Richmond, Virginia, United States, 23249
      • Virginia Beach, Virginia, United States, 23451

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 diagnosed >=1 month before screening;
  • no previous treatment, or previous treatment with no more than 2 oral medications.

Exclusion Criteria:

  • type 1 diabetes;
  • type 2 diabetes treated with insulin or a PPAR gamma agonist during the 3 months before screening;
  • patients who are pregnant, breastfeeding or not using a reliable contraceptive method.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: DPP-IV Inhibitor
Escalating doses po bid or qd
Experimental: 2
Drug: DPP-IV Inhibitor
Escalating doses po bid or qd
Experimental: 3
Drug: DPP-IV Inhibitor
Escalating doses po bid or qd
Experimental: 4
Drug: DPP-IV Inhibitor
Escalating doses po bid or qd
Placebo Comparator: 5
Drug: Placebo
po bid or qd

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absolute change from baseline in HbAlc\n\n
Time Frame: Week 12
Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Absolute change in FPG and absolute/relative change in insulin sensitivity, beta-cell-function, lipid profile, response rate
Time Frame: Week 12
Week 12
AEs, vital signs, laboratory tests, body weight, waist/hip ratio, ECG\n
Time Frame: Throughout study
Throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

July 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

Other Study ID Numbers

  • BM18102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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