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

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ClinicalTrials.gov Identifier: NCT01720290
Recruitment Status : Completed
First Posted : November 2, 2012
Last Update Posted : February 20, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: repaglinide Drug: metformin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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.
Actual Study Start Date : July 25, 2002
Actual Primary Completion Date : February 25, 2003
Actual Study Completion Date : February 25, 2003

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rep Drug: repaglinide
Dose individually adjusted

Active Comparator: Met Drug: metformin
Dose individually adjusted

Active Comparator: Rep + met Drug: repaglinide
Dose individually adjusted

Drug: metformin
Dose at 1000 mg/day




Primary Outcome Measures :
  1. Change in HbA1c (glycosylated haemoglobin A1c)

Secondary Outcome Measures :
  1. Fasting blood glucose (FBG)
  2. 1-hour post prandial blood glucose (PPBG)
  3. Incidence of hypoglycemic episodes


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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01720290


Locations
China, Beijing
Novo Nordisk Investigational Site
Beijing, Beijing, China, 100191
China
Novo Nordisk Investigational Site
Beijing, China, 100029
Novo Nordisk Investigational Site
Shanghai, China
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01720290     History of Changes
Other Study ID Numbers: AGEE-3018
First Posted: November 2, 2012    Key Record Dates
Last Update Posted: February 20, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Repaglinide
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs