DiabetesREPAMETNCT00709917
Observational Study of the Switch of Metformin Alone to Metformin Combined With Repaglinide in Type 2 Diabetes
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 2 sites in 2 countries.
Trial summary
This study is conducted in Europe. The aim of this observational study is to investigate the switch from metformin alone to metformin combined with repaglinide in type 2 diabetic patients not achieving adequate glycaemic control on maximal dose of metformin given alone and to analyse different epidemiological… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- repaglinide
- How many people
- 2,171 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2007to Jan 2008
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Type 2 diabetic patients having failed on metformin monotherapy
Who may be able to join
- Type 2 diabetic patients with inadequate glycaemic control when received metformin alone on maximal dose
- Signed informed consent
- Treatment in accordance with the summary of product characterisation
Who cannot join
- Any contraindication to metformin or repaglinide
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Observational Study Investigating the Efficacy of Switching From Metformin Monotherapy to a Dual Therapy of Metformin and Repaglinide on Glycaemic Control in Type 2 Diabetes
This study is conducted in Europe.
The aim of this observational study is to investigate the switch from metformin alone to metformin combined with repaglinide in type 2 diabetic patients not achieving adequate glycaemic control on maximal dose of metformin given alone and to analyse different epidemiological parameters.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- repaglinide
- 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
Also called AGEE, Prandin®
Start dose and freqency to be prescribed by the physician at his discretion following clinical practice
| Study group | Role | What they receive |
|---|---|---|
| A | Not described Receives: Drug: repaglinide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (number of hypoglycaemic incidents)
Measured: After 10-20 weeks
HbA1C
Measured: After 10-20 weeks
Secondary outcomes (4)
safety
Measured: After 10-20 weeks
posology
Measured: After 10-20 weeks
lifestyle
Measured: After 10-20 weeks
FBG
Measured: After 10-20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2008 (estimated)
- Study startMar 2007
- Primary completionJan 2008
- Study completionJan 2008
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
- Observational
- Time perspective
- Prospective
- Enrolment
- 2,171 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
- NCT00709917
- Sponsor's protocol ID
- AGEE-1857
- Acronym
- REPAMET
- Status last verified
- Mar 2016
- First submitted
- 30 Jun 2008
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study Investigating the Efficacy of Switching From Metformin Monotherapy to a Dual Therapy of Metformin and Repaglinide on Glycaemic Control in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00709917
- Acronym / sponsor ID
- REPAMET / AGEE-1857
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,171 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 3 Jul 2008 (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 study is conducted in Europe.
The aim of this observational study is to investigate the switch from metformin alone to metformin combined with repaglinide in type 2 diabetic patients not achieving adequate glycaemic control on maximal dose of metformin given alone and to analyse different epidemiological parameters.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: repaglinide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 2 diabetic patients having failed on metformin monotherapy
Key inclusion criteria (3 listed)
- Type 2 diabetic patients with inadequate glycaemic control when received metformin alone on maximal dose
- Signed informed consent
- Treatment in accordance with the summary of product characterisation
Key exclusion criteria (1 listed)
- Any contraindication to metformin or repaglinide
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 |
|---|---|---|
| repaglinideAlso: AGEE, Prandin®Start dose and freqency to be prescribed by the physician at his discretion following clinical practice | Drug | A |
Primary outcome
Safety (number of hypoglycaemic incidents)
Time frame: After 10-20 weeks
HbA1C
Time frame: After 10-20 weeks
4 secondary outcomes
safety
Time frame: After 10-20 weeks
posology
Time frame: After 10-20 weeks
lifestyle
Time frame: After 10-20 weeks
FBG
Time frame: After 10-20 weeks
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 3 Mar 2016.
- 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
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 2 sites in 2 countries.
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 1 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 3 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Luxembourg. 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.
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?
Safety (number of hypoglycaemic incidents) (time frame: After 10-20 weeks). The study lists 2 primary outcomes in all. 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 3 Mar 2016; AzTrials last refreshed its copy on 8 Nov 2026.