DiabetesPhase 4NCT01720290
Comparison of Repaglinide and Metformin Administered Alone or in Combination in Type 2 Diabetes
A Phase 4 study testing repaglinide and metformin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- repaglinide and metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesChina
- Study dates
- 25 Jul 2002to 25 Feb 2003
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
China3 sites
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, 100191
Novo Nordisk Investigational Site
Beijing, 100029
Novo Nordisk Investigational Site
Shanghai
About this study
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.
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.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- repaglinide, metformin
- 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
Dose individually adjusted
metforminDrug
Dose individually adjusted
metforminDrug
Dose at 1000 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Rep | Experimental | Not described Receives: Drug: repaglinide |
| Met | Active comparator | Not described Receives: Drug: metformin |
| Rep + met | Active comparator | Not described Receives: Drug: repaglinide; Drug: metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c (glycosylated haemoglobin A1c)
Secondary outcomes (3)
Fasting blood glucose (FBG)
1-hour post prandial blood glucose (PPBG)
Incidence of hypoglycemic episodes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2012 (estimated)
- Study start25 Jul 2002
- Primary completion25 Feb 2003
- Study completion25 Feb 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01720290
- Sponsor's protocol ID
- AGEE-3018
- Status last verified
- Feb 2017
- First submitted
- 31 Oct 2012
- Last updated
- 20 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01720290
- Acronym / sponsor ID
- AGEE-3018
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2002 (actual)
- Primary completion
- 25 Feb 2003 (actual)
- Study completion
- 25 Feb 2003 (actual)
- First posted
- 2 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rep | Experimental | Drug: repaglinide |
| Met | Active comparator | Drug: metformin |
| Rep + met | Active comparator | Drug: repaglinide, Drug: metformin |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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%
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| repaglinideDose individually adjusted | Drug | Rep, Rep + met |
| metforminDose individually adjusted | Drug | Met |
| metforminDose at 1000 mg/day | Drug | Rep + met |
Primary outcome
Change in HbA1c (glycosylated haemoglobin A1c)
3 secondary outcomes
Fasting blood glucose (FBG)
1-hour post prandial blood glucose (PPBG)
Incidence of hypoglycemic episodes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2017.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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
3 sites 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 metformin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 3 sites 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 3 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 20 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 HbA1c (glycosylated haemoglobin A1c). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2017.