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Completed

NCT Number: NCT01720290

Comparison of Repaglinide and Metformin Administered Alone or in Combination in Type 2 Diabetes

This trial is conducted in Asia. The aim of this trial is to compare repaglinide and metformin administered alone or in combination in subjects with type 2 diabetes.

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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

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novo Nordisk Investigational Site, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Previously treated with oral hypoglycaemic agents (OHA) as monotherapy (if metformin, less than 1500 mg daily)
  • Body Mass Index (BMI) of 21-35 kg/m^2
  • HbA1c (glycosylated haemoglobin A1c) between 7.0-10%

Exclusion criteria

  • Treatment with insulin within the last 3 months preceding the trial
  • Uncontrolled treated or untreated hypertension (systolic blood pressure above or equal to 180 mm Hg, and/or diastolic blood pressure above 105 mm Hg)
  • Participation in any other clinical trial within 30 days of screening

Treatment and study plan

repaglinide

Drug

Dose individually adjusted

metformin

Drug

Dose individually adjusted

Primary outcomes

  1. Change in HbA1c (glycosylated haemoglobin A1c)

Secondary outcomes

  1. Fasting blood glucose (FBG)

  2. 1-hour post prandial blood glucose (PPBG)

  3. Incidence of hypoglycemic episodes

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A 3-month, Open-label, Randomized, Multi-center Study of Repaglinide in Combination With Metformin as Compared to Metformin or Repaglinide Given as Monotherapy for the Treatment of Type 2 Diabetes.

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Nov 2, 2012
Registry last updated
Feb 20, 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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