Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effect of Repaglinide and Metformin Combination Tablet or Rosiglitazone and Metformin in Fixed Dose Combination on Blood Glucose Control in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00399711
First received: November 14, 2006
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

This trial is conducted in the United States of America (USA). This trial compares the changes in HbA1c after 26 weeks of repaglinide and metformin fixed dose combination tablet given as twice daily versus three times daily regimens or versus twice daily rosiglitazone and metformin fixed dose combination tablet in subjects with type 2 diabetes currently on monotherapy.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: repaglinide and metformin combination tablet
Drug: rosiglitazone and metformin combination tablet
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Repaglinide and Metformin Combination Tablet (NN4440) in a TID Regimen Compared to a BID Regimen and BID Avandamet in Subjects With Type 2 Diabetes: A Twenty-Six Week, Open-Label, Multicenter, Randomized, Parallel Group Trial to Investigate Efficacy and Safety

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • HbA1c [ Time Frame: After 26 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in 8-point Glucose Profiles [ Designated as safety issue: No ]
  • Change in Lipid Profile [ Designated as safety issue: No ]
  • Events of hypoglycemia [ Designated as safety issue: No ]
  • Safety parameters [ Designated as safety issue: No ]
  • Change in Fasting Plasma Glucose [ Designated as safety issue: No ]
  • Waist/hip ratio change [ Designated as safety issue: No ]
  • Change in body weight [ Designated as safety issue: No ]
  • Percentage of subjects achieving sudden levels of HbA1c [ Designated as safety issue: No ]

Enrollment: 560
Study Start Date: November 2006
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes for at least 3 months
  • HbA1c between 7.5-11.0% on monotherapy or
  • HbA1c between 7.0-10.0% on dual therapy
  • BMI maximum 45 kg/m2

Exclusion Criteria:

  • Any clinically significant disease history in the opinion of the investigator
  • Severe heart disease
  • Pregnancy
  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: NCT00399711

  Show 96 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Campbell Howard, MD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00399711     History of Changes
Other Study ID Numbers: NN4440-1794
Study First Received: November 14, 2006
Last Updated: November 21, 2013
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
Metformin
Repaglinide
Rosiglitazone
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014