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Completed

NCT Number: NCT00399711

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 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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, San Juan, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

repaglinide and metformin combination tablet

Drug

rosiglitazone and metformin combination tablet

Drug

Primary outcomes

  1. HbA1c

    Time frame: After 26 weeks of treatment

Secondary outcomes

  1. Change in 8-point Glucose Profiles

  2. Change in Lipid Profile

  3. Events of hypoglycemia

  4. Safety parameters

  5. Change in Fasting Plasma Glucose

  6. Waist/hip ratio change

  7. Change in body weight

  8. Percentage of subjects achieving sudden levels of HbA1c

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Nov 15, 2006
Registry last updated
Feb 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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