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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00111670
First Posted: May 25, 2005
Last Update Posted: November 2, 2016
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.
Information provided by (Responsible Party):
Hoffmann-La Roche
  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 study 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
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

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 ]

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 ]
  • AEs, vital signs, laboratory tests, body weight, waist/hip ratio, ECG\n [ Time Frame: Throughout study ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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 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
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): 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, 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, 06726
Mexico City, Mexico, 14000
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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00111670     History of Changes
Other Study ID Numbers: BM18102
First Submitted: May 24, 2005
First Posted: May 25, 2005
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