Insulin SensitivityPhase 4ROSINCT02526615
Effects of Rosiglitazone and Metformin on Metabolism in Type 2 Diabetes
A Phase 4 study testing Rosiglitazone and Metformin in people with Insulin Sensitivity and Type 2 Diabetes, run by Turku University Hospital at 3 sites in Finland.
Trial summary
The objectives of this study are to compare the effects of rosiglitazone and metformin on insulin stimulated glucose uptake in subjects with type 2 diabetes. Whole body, and skeletal muscle, heart and adipose tissue insulin stimulated glucose uptake is measured during euglycemic hyperinsulinemic clamp and… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Insulin Sensitivity, Type 2 Diabetes
- What is being tested?
- Rosiglitazone and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 3 sitesFinland
- Study dates
- Oct 2000to Dec 2001
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-75 years,
- BMI 25-35 kg/m2,
- WHO criteria for type 2 diabetes fasting plasma glucose>=7.0 mmol/l on at least 2 separate occasions,
- C-peptide>0.2 nmol/l
Who cannot join
- plasma glucose < 6.1 or >10 mmol/l after the screening period
- cardiac heart failure
- diagnosed coronary heart disease
- severe aortic, mitral or tricuspidal valve disease
- blood pressure > 160/ 100 mg Hg
- any previous or present hepatic (GT >100, alanine amino transferase >3 x upper limit of the reference range) or renal (S-creatinine > 130) disease
Show all 16Show fewer
- pregnancy or lactation
- proliferative retinopathy
- microalbuminuria
- subjects with history of lactate acidosis
- symptomatic polyneuropathy
- antidiabetic medication
- changes in antihypertensive medication or beta-blockers in medication
- metal objects in region of imaging
- anemia with Hb < 100 in mean or < 90 in women
- oral corticosteroid treatment
Trial locations and contacts
3 sites in 1 country.
Finland3 sites
Turku PET Centre
Turku, Turku, 20520
Turku university hospital, PET center
Turku, Turku, 20520
Turku PET Centre (Turku University Hospital)
Turku, 20521
About this study
Official title: Comparison of Effects of Rosiglitazone and Metformin on Myocardial, Skeletal Muscle, Liver and Adipose Tissue Insulin Stimulated Glucose Uptake in Patients With Type 2 Diabetes Mellitus
The objectives of this study are to compare the effects of rosiglitazone and metformin on insulin stimulated glucose uptake in subjects with type 2 diabetes. Whole body, and skeletal muscle, heart and adipose tissue insulin stimulated glucose uptake is measured during euglycemic hyperinsulinemic clamp and positron-emission tomography scanning before and 26 weeks after treatment in 48 newly diagnosed subjects with type 2 diabetes. Subjects will be randomized to receive either rosiglitazone or metformin or placebo, according to a simple randomization procedure with double blinding.
Read the detailed description
Insulin resistance is a pivotal underlying metabolic abnormality in most subjects with type 2 diabetes. Clinical experience has proved metformin to be efficacious treatment in patients with type 2 diabetes. Rosiglitazone is a novel antidiabetic agent, which has been shown to decrease fasting plasma glucose concentrations in animal models and in clinical trials. There are no previous studies that compare the effects of rosiglitazone and metformin on insulin stimulated glucose uptake in subjects with type 2 diabetic in different organs.
PET is very sensitive in detecting changes in glucose uptake and blood flow and, is the method of choice to investigate the effects of medical interventions. Due to sensitivity of these functional parameters only moderate or small number of subjects need to be studied. This makes it feasible to perform tightly controlled intervention studies in a very cost-effective way.
The objectives of this study are to compare the effects of rosiglitazone and metformin on insulin stimulated glucose uptake in subjects with type 2 diabetes. PET measurements on myocardium, skeletal muscle and subcutaneous and visceral fat are performed at baseline and at the end of the treatment period. Furthermore, the effect of exercise on skeletal muscle blood flow and glucose uptake is studied.
The study consists of 48 newly diagnosed subjects with type 2 diabetes. Subjects will be randomized to receive either rosiglitazone or metformin or placebo, according to a simple randomization procedure with double blinding. The investigators will also study ten age-matched non-diabetic control subjects, who will undergo the same PET study procedure as subjects with type 2 diabetes.
A study of the effects of antidiabetic oral medication in newly diagnosed subjects with type 2 diabetes is of great importance for the understanding of the differences in mode of action of the different antidiabetic drugs. Such a study would contribute to elucidate advantages and disadvantages with certain drugs and potential additive effects in combination therapy.
- Conditions
- Insulin Sensitivity, Type 2 Diabetes
- Being tested
- Rosiglitazone, Metformin, Placebo
- Keywords
- rosiglitazone, metformin, muscle
- Medical subject headings
- Insulin Resistance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosiglitazoneDrug
Also called Avandia
Patients received either placebo, metformin or rosiglitazone
MetforminDrug
Patients received either placebo, metformin or rosiglitazone
PlaceboDrug
Patients received either placebo, metformin or rosiglitazone
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | placebo, 2 tablets per day Receives: Drug: Placebo |
| Metformin | Active comparator | 500mg 1 tablet 2 times per day for the first 2 weeks, then after that 2 tables 2 times per day Receives: Drug: Metformin |
| Rosiglitazone | Active comparator | 2 mg 1 tablets 2 times per day for the first 2 weeks, then after that 2 tablets 2 times per day Receives: Drug: Rosiglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin sensitivity in skeletal muscle
pre and at 26 weeks measured with euglycemic clamp and 18-F-2-fluoro-2-deoxy-D-glucose scanning skeletal muscle
Measured: 26 weeks
Secondary outcomes (4)
skeletal muscle blood flow
measured using PET scanning
Measured: 26 weeks
insulin signaling pathways in skeletal muscle
measured from muscle biopsies taken before and after intervention
Measured: 26 weeks
insulin sensitivity of bone marrow fat
measured using PET images
Measured: 26 weeks
insulin stimulated intestinal glucose uptake
measured using PET images
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study startOct 2000
- Primary completionDec 2001
- Study completionDec 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insulin SensitivityStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- SmithKline Beecham
- Responsible party
- Sponsor
- Investigators
- Pirjo Nuutila, MD, PhD, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02526615
- Sponsor's protocol ID
- TurkuUH-ROSI
- Acronym
- ROSI
- Status last verified
- Aug 2015
- First submitted
- 11 Aug 2015
- Last updated
- 18 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Koffert JP, Mikkola K, Virtanen KA, Andersson AD, Faxius L, Hallsten K, Heglind M, Guiducci L, Pham T, Silvola JMU, Virta J, Eriksson O, Kauhanen SP, Saraste A, Enerback S, Iozzo P, Parkkola R, Gomez MF, Nuutila P. Metformin treatment significantly enhances intestinal glucose uptake in patients with type 2 diabetes: Results from a randomized clinical trial. Diabetes Res Clin Pract. 2017 Sep;131:208-216. doi: 10.1016/j.diabres.2017.07.015. Epub 2017 Jul 20.
PubMed 28778047
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effects of Rosiglitazone and Metformin on Myocardial, Skeletal Muscle, Liver and Adipose Tissue Insulin Stimulated Glucose Uptake in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02526615
- Acronym / sponsor ID
- ROSI / TurkuUH-ROSI
- Conditions
- Insulin Sensitivity, Type 2 Diabetes
- Keywords
- rosiglitazone, metformin, muscle
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- SmithKline Beecham
- Study start
- Oct 2000
- Primary completion
- Dec 2001 (actual)
- Study completion
- Dec 2001 (actual)
- First posted
- 18 Aug 2015 (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.
The objectives of this study are to compare the effects of rosiglitazone and metformin on insulin stimulated glucose uptake in subjects with type 2 diabetes. Whole body, and skeletal muscle, heart and adipose tissue insulin stimulated glucose uptake is measured during euglycemic hyperinsulinemic clamp and positron-emission tomography scanning before and 26 weeks after treatment in 48 newly diagnosed subjects with type 2 diabetes. Subjects will be randomized to receive either rosiglitazone or metformin or placebo, according to a simple randomization procedure with double blinding.
Detailed description
Insulin resistance is a pivotal underlying metabolic abnormality in most subjects with type 2 diabetes. Clinical experience has proved metformin to be efficacious treatment in patients with type 2 diabetes. Rosiglitazone is a novel antidiabetic agent, which has been shown to decrease fasting plasma glucose concentrations in animal models and in clinical trials. There are no previous studies that compare the effects of rosiglitazone and metformin on insulin stimulated glucose uptake in subjects with type 2 diabetic in different organs.
PET is very sensitive in detecting changes in glucose uptake and blood flow and, is the method of choice to investigate the effects of medical interventions. Due to sensitivity of these functional parameters only moderate or small number of subjects need to be studied. This makes it feasible to perform tightly controlled intervention studies in a very cost-effective way.
The objectives of this study are to compare the effects of rosiglitazone and metformin on insulin stimulated glucose uptake in subjects with type 2 diabetes. PET measurements on myocardium, skeletal muscle and subcutaneous and visceral fat are performed at baseline and at the end of the treatment period. Furthermore, the effect of exercise on skeletal muscle blood flow and glucose uptake is studied.
The study consists of 48 newly diagnosed subjects with type 2 diabetes. Subjects will be randomized to receive either rosiglitazone or metformin or placebo, according to a simple randomization procedure with double blinding. The investigators will also study ten age-matched non-diabetic control subjects, who will undergo the same PET study procedure as subjects with type 2 diabetes.
A study of the effects of antidiabetic oral medication in newly diagnosed subjects with type 2 diabetes is of great importance for the understanding of the differences in mode of action of the different antidiabetic drugs. Such a study would contribute to elucidate advantages and disadvantages with certain drugs and potential additive effects in combination therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placeboplacebo, 2 tablets per day |
| Metformin | Active comparator | Drug: Metformin500mg 1 tablet 2 times per day for the first 2 weeks, then after that 2 tables 2 times per day |
| Rosiglitazone | Active comparator | Drug: Rosiglitazone2 mg 1 tablets 2 times per day for the first 2 weeks, then after that 2 tablets 2 times per day |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 40-75 years,
- BMI 25-35 kg/m2,
- WHO criteria for type 2 diabetes fasting plasma glucose>=7.0 mmol/l on at least 2 separate occasions,
- C-peptide>0.2 nmol/l
Key exclusion criteria (16 listed)
- plasma glucose < 6.1 or >10 mmol/l after the screening period
- cardiac heart failure
- diagnosed coronary heart disease
- severe aortic, mitral or tricuspidal valve disease
- blood pressure > 160/ 100 mg Hg
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 |
|---|---|---|
| RosiglitazoneAlso: AvandiaPatients received either placebo, metformin or rosiglitazone | Drug | Rosiglitazone |
| MetforminPatients received either placebo, metformin or rosiglitazone | Drug | Metformin |
| PlaceboPatients received either placebo, metformin or rosiglitazone | Drug | Placebo |
Primary outcome
insulin sensitivity in skeletal muscle
Time frame: 26 weeks
pre and at 26 weeks measured with euglycemic clamp and 18-F-2-fluoro-2-deoxy-D-glucose scanning skeletal muscle
4 secondary outcomes
skeletal muscle blood flow
Time frame: 26 weeks
insulin signaling pathways in skeletal muscle
Time frame: 26 weeks
insulin sensitivity of bone marrow fat
Time frame: 26 weeks
insulin stimulated intestinal glucose uptake
Time frame: 26 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 18 Aug 2015.
- Derived from this study: PubMed 28778047Koffert JP, Mikkola K, Virtanen KA, Andersson AD, Faxius L, Hallsten K, Heglind M, Guiducci L, Pham T, Silvola JMU, Virta J, Eriksson O, Kauhanen SP, Saraste A, Enerback S, Iozzo P, Parkkola R, Gomez MF, Nuutila P. Metformin treatment significantly enhances intestinal glucose uptake in patients with type 2 diabetes: Results from a randomized clinical trial. Diabetes Res Clin Pract. 2017 Sep;131:208-216. doi: 10.1016/j.diabres.2017.07.015. Epub 2017 Jul 20.
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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.
Pirjo Nuutila, MD, PhD principal investigator
Turku University Hospital
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 Rosiglitazone and Metformin in people with Insulin Sensitivity and Type 2 Diabetes, run by Turku University Hospital at 3 sites in Finland.
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 4 inclusion and 16 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 18 Aug 2015. 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 Finland. 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. Some participants in this study may receive a placebo. 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?
insulin sensitivity in skeletal muscle (time frame: 26 weeks). 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 NCT02526615, which also lists 1 linked publication.
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 18 Aug 2015.