Diabetes Mellitus, Type 2Phase 4NCT00118950
Effect of Metformin Versus Repaglinide Treatment in Non-Obese Type 2 Diabetic Patients Uncontrolled by Diet
A Phase 4 study testing Metformin, Repaglinide and Diet-only. in people with Diabetes Mellitus, Type 2, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
Trial summary
Background: Metformin is the first drug of choice in obese patients with type-2 diabetes (T2DM) due to its antiglycaemic as well as its cardiovascular protective potentials. In non-obese T2DM patients insulin-secretagogues are empirically used as first choice. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Metformin, Repaglinide and Diet-only.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2001to Mar 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type-2 diabetes, defined as:
- Age at onset of diabetes ≥ 40 years
- Fasting serum C-peptide ≥ 300 pmol/l or a non-fasting or glucagon-stimulated serum C-peptide ≥ 600 pmol/l
- No history of ketonuria or ketoacidosis.
- BMI ≤ 27 kg/m2.
- Fasting plasma-glucose ≥ 6.5 mmol/l after at least one month of diet-only treatment.
- HbA1c ≤ 9.5% at ongoing oral anti-hyperglycaemic agents. HbA1c ≥ 6.5% after minimum one month of diet-only treatment.
- Weight-loss of no more than 5.0 kg during the last 6 months prior to enrolment.
Who cannot join
- Type-1 diabetes
- Insulin-treated type-2 diabetes
- Secondary diabetes, heart-failure
- Serum-creatinine above the upper limit
- Serum-ASAT elevated more than 3 fold above the upper limit
- Factor II-VII-X decreased below 0.7
Show all 10Show fewer
- Ongoing coexisting illnesses with a life-shortening prognosis
- Mental retardation or reduced intellectual behaviour
- Pregnancy
- History of drug-abuse or HbA1c>10.5% at two separate visits with at least one month interval during treatment-periods.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Metformin Versus Repaglinide Treatment on Glycemic Control and Non-Glycaemic Cardiovascular Risk Factors in Non-Obese Type 2 Diabetic Patients Uncontrolled by Diet
Background: Metformin is the first drug of choice in obese patients with type-2 diabetes (T2DM) due to its antiglycaemic as well as its cardiovascular protective potentials. In non-obese T2DM patients insulin-secretagogues are empirically used as first choice. The aim of this study was to evaluate the effect of metformin versus an insulin-secretagogue, repaglinide on glycaemic regulation and non-glycaemic cardiovascular risk markers in non-obese patients with T2DM.
Methods: Single-center, randomised, double-masked, double-dummy, cross-over-study of 96 non-obese (BMI ≤ 27 kg/m2) Caucasian T2DM-patients. After a one month run-in on diet-only treatment, patients were randomised to either repaglinide 2mg three times a day (t.i.d). followed by metformin 1g twice a day (b.i.d.) or vice versa each for a period of four months with a one month wash-out between interventions.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Metformin, Repaglinide, Placebo-Metformin., Placebo-Repaglinide., Diet-only.
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Tablet Metformin 500 mg; Dosage: 1000 mg two times daily. Duration: Four months.
RepaglinideDrug
Tablet Repaglinide 1 mg; Dosage: 2 mg three times daily. Duration: Four months.
Placebo-Metformin.Drug
Tablet Placebo (corresponding to 500 mg Metformin). Dosage: 2 tablets two times daily. Duration: Four months.
Placebo-Repaglinide.Drug
Tablet Placebo (corresponding to 1 mg Repaglinide). Dosage: 2 tablets three times daily. Duration: Four months.
Diet-only.Other
Diet-only treatment. Duration: One month.
| Study group | Role | What they receive |
|---|---|---|
| 4 | Active comparator | Metformin plus placebo-Repgalinide. Double-masked, randomized. Duration: Four months. Receives: Drug: Metformin; Drug: Placebo-Repaglinide. |
| 2 | Active comparator | Repaglinide plus Placebo-Metformin. Double-masked, randomized. Duration: Four months. Receives: Drug: Repaglinide; Drug: Placebo-Metformin. |
| 1 | Other | Run-in period: Treatment: Diet-only. Duration: One month. Receives: Other: Diet-only. |
| 3 | Other | Wash-out period: Treatment: Diet-only: Duration: One month. Receives: Other: Diet-only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HaemoglobinA1c
Secondary outcomes (9)
Home-monitored 7-point plasma-glucose profiles
Body-weight
Waist- and hip-circumference
Fasting and postprandial (after a standard test-meal) measures of plasma-glucose, insulin, c-peptide, free fatty acids, lipoproteins, triglycerides and other markers related to lipid-metabolism (e.g. apo-lipoproteins, lipoprotein particle size etc.).
Biomarkers related to inflammation, endothelial dysfunction and fibrinolysis (e.g. hs-CRP, TNF-alpha, IL-6, ICAM, VCAM, E-selectin, vWF, PAI-1 and t-PA, adiponectin, ADMA, AGE-peptides).
Albuminuria and 24-hour blood-pressure measurements.
Platelet aggregation, markers of platelet activity and fibrinolytic markers fasting as well as before and after physical activity.
DNA for genotyping.
Adverse events and safety variables (e.g. hypoglycaemia, haemoglobin, white blood cell count, cobalamine and folate).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2005 (estimated)
- Study startMar 2001
- Study completionMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Investigators
- Allan A Vaag, M. D., Chief Physician, Study chair, Steno Diabetes Center CopenhagenSoeren S Lund, M. D., Principal investigator, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00118950
- Sponsor's protocol ID
- ReMet
- Status last verified
- Dec 2008
- First submitted
- 1 Jul 2005
- Last updated
- 8 Dec 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Metformin Versus Repaglinide Treatment on Glycemic Control and Non-Glycaemic Cardiovascular Risk Factors in Non-Obese Type 2 Diabetic Patients Uncontrolled by Diet
- ClinicalTrials.gov ID
- NCT00118950
- Acronym / sponsor ID
- ReMet
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Study start
- Mar 2001
- Study completion
- Mar 2003
- First posted
- 12 Jul 2005 (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.
Background: Metformin is the first drug of choice in obese patients with type-2 diabetes (T2DM) due to its antiglycaemic as well as its cardiovascular protective potentials. In non-obese T2DM patients insulin-secretagogues are empirically used as first choice. The aim of this study was to evaluate the effect of metformin versus an insulin-secretagogue, repaglinide on glycaemic regulation and non-glycaemic cardiovascular risk markers in non-obese patients with T2DM.
Methods: Single-center, randomised, double-masked, double-dummy, cross-over-study of 96 non-obese (BMI ≤ 27 kg/m2) Caucasian T2DM-patients. After a one month run-in on diet-only treatment, patients were randomised to either repaglinide 2mg three times a day (t.i.d). followed by metformin 1g twice a day (b.i.d.) or vice versa each for a period of four months with a one month wash-out between interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 4 | Active comparator | Drug: Metformin, Drug: Placebo-Repaglinide.Metformin plus placebo-Repgalinide. Double-masked, randomized. Duration: Four months. |
| 2 | Active comparator | Drug: Repaglinide, Drug: Placebo-Metformin.Repaglinide plus Placebo-Metformin. Double-masked, randomized. Duration: Four months. |
| 1 | Other | Other: Diet-only.Run-in period: Treatment: Diet-only. Duration: One month. |
| 3 | Other | Other: Diet-only.Wash-out period: Treatment: Diet-only: Duration: One month. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age at onset of diabetes ≥ 40 years
- Fasting serum C-peptide ≥ 300 pmol/l or a non-fasting or glucagon-stimulated serum C-peptide ≥ 600 pmol/l
- No history of ketonuria or ketoacidosis.
- BMI ≤ 27 kg/m2.
- Fasting plasma-glucose ≥ 6.5 mmol/l after at least one month of diet-only treatment.
Key exclusion criteria (10 listed)
- Type-1 diabetes
- Insulin-treated type-2 diabetes
- Secondary diabetes, heart-failure
- Serum-creatinine above the upper limit
- Serum-ASAT elevated more than 3 fold above the upper limit
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 |
|---|---|---|
| MetforminTablet Metformin 500 mg; Dosage: 1000 mg two times daily. Duration: Four months. | Drug | 4 |
| RepaglinideTablet Repaglinide 1 mg; Dosage: 2 mg three times daily. Duration: Four months. | Drug | 2 |
| Placebo-Metformin.Tablet Placebo (corresponding to 500 mg Metformin). Dosage: 2 tablets two times daily. Duration: Four months. | Drug | 2 |
| Placebo-Repaglinide.Tablet Placebo (corresponding to 1 mg Repaglinide). Dosage: 2 tablets three times daily. Duration: Four months. | Drug | 4 |
| Diet-only.Diet-only treatment. Duration: One month. | Other | 1, 3 |
Primary outcome
HaemoglobinA1c
9 secondary outcomes
Home-monitored 7-point plasma-glucose profiles
Body-weight
Waist- and hip-circumference
Fasting and postprandial (after a standard test-meal) measures of plasma-glucose, insulin, c-peptide, free fatty acids, lipoproteins, triglycerides and other markers related to lipid-metabolism (e.g. apo-lipoproteins, lipoprotein particle size etc.).
Biomarkers related to inflammation, endothelial dysfunction and fibrinolysis (e.g. hs-CRP, TNF-alpha, IL-6, ICAM, VCAM, E-selectin, vWF, PAI-1 and t-PA, adiponectin, ADMA, AGE-peptides).
Albuminuria and 24-hour blood-pressure measurements.
Platelet aggregation, markers of platelet activity and fibrinolytic markers fasting as well as before and after physical activity.
DNA for genotyping.
Adverse events and safety variables (e.g. hypoglycaemia, haemoglobin, white blood cell count, cobalamine and folate).
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 8 Dec 2008.
Related trials for Diabetes Mellitus, Type 2
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
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Allan A Vaag, M. D., Chief Physician study chair
Steno Diabetes Center Copenhagen
Soeren S Lund, M. D. principal investigator
Steno Diabetes Center Copenhagen
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 Metformin, Repaglinide and Diet-only. in people with Diabetes Mellitus, Type 2, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
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 8 inclusion and 10 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 8 Dec 2008. 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 Denmark. 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?
HaemoglobinA1c. 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 8 Dec 2008.