DiabetesPhase 4NCT01022762

Comparison of Repaglinide and Gliclazide in Chinese Subjects With Type 2 Diabetes Never Received Oral Antidiabetic Drug Treatment

A Phase 4 study testing repaglinide and gliclazide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood glucose lowering effect and the safety profile of repaglinide given alone compared to gliclazide given alone in Chinese subjects with type 2 diabetes who never have been treated with oral anti-diabetic drugs (OADs). Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Diabetes, Diabetes Mellitus, Type 2
What is being tested?: repaglinide and gliclazide
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 440 participants
Where: 1 siteChina
Study dates: Nov 2009to Nov 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Type 2 diabetes
Oral anti-diabetic drug (OAD) naïve (unsystematic OAD treatment 6 months prior to this trial is allowed)
Insulin naïve (less than 1 week of daily use of insulin therapy before trial start is allowed)
Lipid-lowing agent naïve
HbA1c: 6.5-8.5%
Fasting glucose: 6.1-13.0 mmol/L (110-234 mg/dl)

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Body Mass Index (BMI): 20-35 kg/m^2
Be able and willing to perform self-monitored plasma glucose (SMPG)
Be able and willing to eat 3 main meals per day
Only applicable to subjects who will participate in the subgroup study: Be able and willing to perform and complete IVGTT (intravenous glucose tolerance test) at additional visits

Who cannot join

Known or suspected allergy to repaglinide, gliclazide, or related products (for example sulfonamide or other sulphonylureas (SUs)), or any of the excipients in the study drugs
Previous participation in this study
Participation in a study of another investigational drug within 1 month prior to study start

Trial locations and contacts

1 site in 1 country.

China1 site

Study site
Shanghai, Shanghai Municipality, 200025

Other trials in China

About this study

Official title: A 16-week, Multicentre, Randomised, Open-label, Parallel Group Study to Investigate the Efficacy and Safety Profiles of Repaglinide Monotherapy Compared to Gliclazide Monotherapy in Chinese Antidiabetic-naïve Subjects With Type 2 Diabetes

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: repaglinide, gliclazide
Medical subject headings: Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

repaglinideDrug
Individually adjusted dose for 16 weeks
gliclazideDrug
Individually adjusted dose for 16 weeks

Study groups in NCT01022762
Study group	Role	What they receive
repaglinide	Active comparator	1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily Receives: Drug: repaglinide
gliclazide	Active comparator	80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily Receives: Drug: gliclazide

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Glycosylated Haemoglobin (HbA1c)
Measured: Week 0, week 16

Secondary outcomes (10)

Change in Fasting Plasma Glucose
Measured: Week 0, week 16
Change in 2-hour Postprandial Plasma Glucose (PPG) Over a Standard Meal
A standard meal contains 100g carbohydrate
Measured: Week 0, week 16
Percentage of Participants Achieving the Treatment Target of HbA1c Below or Equal to 6.5%
Measured: Week 16
Change in Fasting Serum Free Fatty Acid (FFA) From Baseline
Measured: Week 0, week 16
Change in 2-hour Postprandial Serum Free Fatty Acid (FFA) Over a Standard Meal
Measured: Week 0, week 16
Change in AUC0-180 of Serum Insulin Concentration of IVGTT (Intravenous Glucose Tolerance Test)
Measured: Over the course of three hours at Week 0 and Week 16
Change in AUC0-180 of Plasma Glucose Concentration of IVGTT
Measured: Over the course of three hours at Week 0 and Week 16
Number of All Treatment Emergent Hypoglycaemic Episodes
A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of trial product and no later than the last day of the trial product.
Measured: Weeks 0-16
Cholesterol
The number of participants having a change in cholesterol from "normal" to "abnormal". "Abnormal" means a value of blood cholesterol is out of the normal range.
Measured: Week 0, week 16
Change in Body Weight
Measured: Week 0, week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2009Nov 2010

First posted1 Dec 2009 (estimated)
Study startNov 2009
Primary completionNov 2010
Study completionNov 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DiabetesStudies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 440 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01022762
Sponsor's protocol ID: AGEE-3783
Other IDs: U1111-1111-9453
Status last verified: Jun 2014
First submitted: 26 Nov 2009
Last updated: 9 Jul 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 16-week, Multicentre, Randomised, Open-label, Parallel Group Study to Investigate the Efficacy and Safety Profiles of Repaglinide Monotherapy Compared to Gliclazide Monotherapy in Chinese Antidiabetic-naïve Subjects With Type 2 Diabetes
ClinicalTrials.gov ID: NCT01022762
Acronym / sponsor ID: AGEE-3783
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 440 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Nov 2009
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 1 Dec 2009 (estimated)
Results: Posted 29 Dec 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
repaglinide	Active comparator	Drug: repaglinide1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
gliclazide	Active comparator	Drug: gliclazide80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Type 2 diabetes
Oral anti-diabetic drug (OAD) naïve (unsystematic OAD treatment 6 months prior to this trial is allowed)
Insulin naïve (less than 1 week of daily use of insulin therapy before trial start is allowed)
Lipid-lowing agent naïve
HbA1c: 6.5-8.5%

Key exclusion criteria (3 listed)

Known or suspected allergy to repaglinide, gliclazide, or related products (for example sulfonamide or other sulphonylureas (SUs)), or any of the excipients in the study drugs
Previous participation in this study
Participation in a study of another investigational drug within 1 month prior to study start

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
repaglinideIndividually adjusted dose for 16 weeks	Drug	repaglinide
gliclazideIndividually adjusted dose for 16 weeks	Drug	gliclazide

Primary outcome

Change in Glycosylated Haemoglobin (HbA1c)
Time frame: Week 0, week 16

10 secondary outcomes

Change in Fasting Plasma Glucose
Time frame: Week 0, week 16
Change in 2-hour Postprandial Plasma Glucose (PPG) Over a Standard Meal
Time frame: Week 0, week 16
Percentage of Participants Achieving the Treatment Target of HbA1c Below or Equal to 6.5%
Time frame: Week 16
Change in Fasting Serum Free Fatty Acid (FFA) From Baseline
Time frame: Week 0, week 16
Change in 2-hour Postprandial Serum Free Fatty Acid (FFA) Over a Standard Meal
Time frame: Week 0, week 16
Change in AUC0-180 of Serum Insulin Concentration of IVGTT (Intravenous Glucose Tolerance Test)
Time frame: Over the course of three hours at Week 0 and Week 16
Change in AUC0-180 of Plasma Glucose Concentration of IVGTT
Time frame: Over the course of three hours at Week 0 and Week 16
Number of All Treatment Emergent Hypoglycaemic Episodes
Time frame: Weeks 0-16
Cholesterol
Time frame: Week 0, week 16
Change in Body Weight
Time frame: Week 0, week 16

Results and safety

Results posted to the registry on 29 Dec 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Repaglinide	218	196
Gliclazide	222	194

Primary outcome: Change in Glycosylated Haemoglobin (HbA1c)

Time frame: Week 0, week 16. Least squares mean (Standard Error). Unit: percentage (%) of total haemoglobin

Measure	Repaglinide n = 206	Gliclazide n = 202
Value	-0.857 (0.051)	-0.871 (0.051)

Repaglinide vs Gliclazide: Mean Difference (Net): 0.014 (95% CI -0.115 to 0.143), ANCOVA

Population analysed: Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation. Missing values were replaced with the last post-baseline data based on LOCF (last observation carried forward).

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: The adverse events were collected in a timespan of 16 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Repaglinide	3 of 216 (1.4%)	0 of 216 (0%)	Not reported
Gliclazide	0 of 219 (0%)	0 of 219 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Clinical Trials at Novo NordiskLink provided by the sponsor.

Related trials for Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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Recruiting
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Registry (GCR, 1452) study director

Novo Nordisk A/S

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing repaglinide and gliclazide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Glycosylated Haemoglobin (HbA1c) (time frame: Week 0, week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01022762.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2014.