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:
NCT00111670
First received: May 24, 2005
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

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 s tudy treatment is < 3 months and the target sample size is 100-500 individuals.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: DPP-IV Inhibitor
Drug: Placebo
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Absolute change from baseline in HbAlc\n\n [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Absolute change in FPG and absolute/relative change in insulin sensitivity, beta-cell-function, lipid profile, response rate [ Time Frame: Week 12 ] [ 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: 291
Study Start Date: June 2005
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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 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.
  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: NCT00111670

  Hide Study Locations
Locations
United States, California
Salinas, California, United States, 93901
United States, Florida
Clearwater, Florida, United States, 33765
Hialeah, Florida, United States, 33013
Pembroke Pines, Florida, United States, 33029
United States, Georgia
Blue Ridge, Georgia, United States, 30513
United States, Illinois
Aurora, Illinois, United States, 60504
United States, Maryland
Elkton, Maryland, United States, 21921
Oxon Hill, Maryland, United States, 20745
United States, Michigan
Troy, Michigan, United States, 48098
United States, Nevada
Pahrump, Nevada, United States, 89048
United States, Ohio
Cincinnati, Ohio, United States, 45224
United States, Oregon
Portland, Oregon, United States, 97239
United States, Pennsylvania
Warminster, Pennsylvania, United States, 18974
United States, Texas
Dallas, Texas, United States, 75246
Midland, Texas, United States, 79707
San Antonio, Texas, United States, 78229
United States, Virginia
Richmond, Virginia, United States, 23249
Virginia Beach, Virginia, United States, 23451
Bulgaria
Ruse, Bulgaria, 7002
Sofia, Bulgaria, 1606
Sofia, Bulgaria, 1233
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
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: NCT00111670     History of Changes
Other Study ID Numbers: BM18102
Study First Received: May 24, 2005
Last Updated: October 6, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 29, 2014