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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
repaglinide
metformin
metformin
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Rep

Met

Rep + met

Arm Description

Outcomes

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

Full Information

First Posted
October 31, 2012
Last Updated
February 17, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01720290
Brief Title
Comparison of Repaglinide and Metformin Administered Alone or in Combination in Type 2 Diabetes
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
July 25, 2002 (Actual)
Primary Completion Date
February 25, 2003 (Actual)
Study Completion Date
February 25, 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rep
Arm Type
Experimental
Arm Title
Met
Arm Type
Active Comparator
Arm Title
Rep + met
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
repaglinide
Intervention Description
Dose individually adjusted
Intervention Type
Drug
Intervention Name(s)
metformin
Intervention Description
Dose individually adjusted
Intervention Type
Drug
Intervention Name(s)
metformin
Intervention Description
Dose at 1000 mg/day
Primary Outcome Measure Information:
Title
Change in HbA1c (glycosylated haemoglobin A1c)
Secondary Outcome Measure Information:
Title
Fasting blood glucose (FBG)
Title
1-hour post prandial blood glucose (PPBG)
Title
Incidence of hypoglycemic episodes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Shanghai
Country
China

12. IPD Sharing Statement

Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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