NCT00819741|CompletedPhase 4Results

Comparison of the Blood Sugar Lowering Effect Between Repaglinide Plus Metformin and Repaglinide Alone in Type 2 Diabetics Not Previously Treated With Oral Sugar-lowering Drugs

A 16-week, Open-label, Multicentre, Randomised, Parallel Study to Evaluate Efficacy and Safety of Repaglinide and Metformin Combination Therapy Compared to Repaglinide Monotherapy in Chinese OAD Naive Type 2 Diabetic Patients

Novo Nordisk A/S ClinicalTrials.gov

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1 other identifier

AGEE-3705

Study Type

interventional

Target

433

Locations

1 country

Sites

Timeline

RegisteredJan 2009

StartedFeb 2009

CompletionNov 2009

Brief Summary

This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood sugar lowering effect of repaglinide plus metformin as initial treatment compared to repaglinide alone in Chinese subjects with type 2 diabetes having an HbA1c (glycosylated haemoglobin A1c) over 8.5 % and who never have taken oral sugar-lowering drugs before. The associated unfavourable events including low blood sugar episodes between the two treatments are also compared.

Trial Health

On Track

Trial Health Score

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

Enrollment

433

participants targeted

Target at P75+ for phase_4 diabetes

Timeline

Completed

Started Feb 2009

Shorter than P25 for phase_4 diabetes

Geographic Reach

1 country

17 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

9 months study duration

First Submitted

Initial submission to the registry

January 8, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

January 9, 2009

Completed

23 days until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

December 8, 2010

Completed

Last Updated

February 10, 2017

Status Verified

December 1, 2016

Enrollment Period

9 months

First QC Date

January 8, 2009

Results QC Date

November 5, 2010

Last Update Submit

December 19, 2016

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in Glycosylated Haemoglobin A1c (HbA1c)
Calculated as an estimate of the mean change in HbA1c after 16 weeks of treatment.
week -2 (screening), week 16

Secondary Outcomes (14)

Change in Fasting Plasma Glucose
week 0, week 16
Change in 2-hour Postprandial Plasma Glucose
Week 0, week 16
Change in 7-point Plasma Glucose Profile
Week 0, week 16
Change in Fasting Serum Insulin
Week 0, week 16
Change in 2-hour Postprandial Serum Insulin
Week 0, week 16
+9 more secondary outcomes

Study Arms (2)

Repaglinide + metformin

EXPERIMENTAL

Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.

Drug: repaglinideDrug: metformin

Repaglinide

ACTIVE COMPARATOR

Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.

Drug: repaglinide

Interventions

repaglinideDRUG

The dose was started from repaglinide 1 mg plus metformin 500 mg once daily. During the dose titration period, the dose could be titrated up to repaglinide 4 mg and metformin 500mg three times daily, according to fasting glucose. the minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily

Repaglinide + metformin

metforminDRUG

The dose was started from repaglinide 1 mg plus metformin 500 mg once daily. During the dose titration period, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose. the minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily

Repaglinide + metformin

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Diagnosed with type 2 diabetes
Never taken oral antidiabetic drugs before
HbA1c greater than 8.5 %
BMI (Body Mass Index) less than or equal to 35 kg/m\^2

You may not qualify if:

Known or suspected allergy to repaglinide, metformin, or any of the excipients in the medications
Taken an investigational drug in another clinical trial within 4 weeks prior to this trial
Impaired liver function, defined as ASAT (aspartate aminotransferase) or ALAT (alanine aminotransferase) equal to or greater than 2 times upper normal limit
Have a clinically significant, active disease of the gastrointestinal, pulmonary, neurological, renal, genitourinary, and haematological systems
Severe uncontrolled or untreated hypertension (sitting diastolic blood pressure (BP) equal to or greater than 100 mmHg or systolic BP equal to or greater than 180 mmHg)
Impaired renal function
Acute or chronic acidosis or if there are plans to have a radiographic material containing iodine
Have a clinically significant, active cardiovascular disease, or decompensated heart failure
Treatment with systemic corticosteroids within the past two months prior to screening

Contact the study team to confirm eligibility.