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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01720290
First received: October 31, 2012
Last updated: February 17, 2017
Last verified: February 2017
  Purpose
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 Intervention Phase
Diabetes Diabetes Mellitus, Type 2 Drug: repaglinide Drug: metformin Phase 4

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


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

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

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

Enrollment: 150
Actual Study Start Date: July 25, 2002
Study Completion Date: February 25, 2003
Primary Completion Date: February 25, 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
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
  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: 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
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01720290     History of Changes
Other Study ID Numbers: AGEE-3018
Study First Received: October 31, 2012
Last Updated: February 17, 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

ClinicalTrials.gov processed this record on September 21, 2017