NCT01720290

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4 diabetes

Timeline
Completed

Started Jul 2002

Shorter than P25 for phase_4 diabetes

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 25, 2002

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2003

Completed
9.7 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2012

Completed
Last Updated

February 20, 2017

Status Verified

February 1, 2017

Enrollment Period

7 months

First QC Date

October 31, 2012

Last Update Submit

February 17, 2017

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c (glycosylated haemoglobin A1c)

Secondary Outcomes (3)

  • Fasting blood glucose (FBG)

  • 1-hour post prandial blood glucose (PPBG)

  • Incidence of hypoglycemic episodes

Study Arms (3)

Rep

EXPERIMENTAL
Drug: repaglinide

Met

ACTIVE COMPARATOR
Drug: metformin

Rep + met

ACTIVE COMPARATOR
Drug: repaglinideDrug: metformin

Interventions

repaglinideDRUG

Dose individually adjusted

RepRep + met
metforminDRUG

Dose individually adjusted

Met

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Novo Nordisk Investigational Site

Beijing, Beijing Municipality, 100191, China

Location

Novo Nordisk Investigational Site

Beijing, 100029, China

Location

Novo Nordisk Investigational Site

Shanghai, China

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

repaglinideMetformin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2012

First Posted

November 2, 2012

Study Start

July 25, 2002

Primary Completion

February 25, 2003

Study Completion

February 25, 2003

Last Updated

February 20, 2017

Record last verified: 2017-02

Locations

CN(3)