NCT02526615

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2000

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2000

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2001

Completed
13.7 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 18, 2015

Completed
Last Updated

August 18, 2015

Status Verified

August 1, 2015

Enrollment Period

1.2 years

First QC Date

August 11, 2015

Last Update Submit

August 14, 2015

Conditions

Insulin SensitivityType 2 Diabetes

Keywords

rosiglitazonemetforminmuscle

Outcome Measures

Primary Outcomes (1)

  • 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

    26 weeks

Secondary Outcomes (4)

  • skeletal muscle blood flow

    26 weeks

  • insulin signaling pathways in skeletal muscle

    26 weeks

  • insulin sensitivity of bone marrow fat

    26 weeks

  • insulin stimulated intestinal glucose uptake

    26 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

placebo, 2 tablets per day

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

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

Drug: Rosiglitazone

Interventions

RosiglitazoneDRUG

Patients received either placebo, metformin or rosiglitazone

Also known as: Avandia
Rosiglitazone
MetforminDRUG

Patients received either placebo, metformin or rosiglitazone

Metformin
PlaceboDRUG

Patients received either placebo, metformin or rosiglitazone

Placebo

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Turku PET Centre

Turku, Turku, 20520, Finland

Location

Turku university hospital, PET center

Turku, Turku, 20520, Finland

Location

Turku PET Centre (Turku University Hospital)

Turku, 20521, Finland

Location

Related Publications (1)

  • 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.

    PMID: 28778047DERIVED

MeSH Terms

Conditions

Insulin ResistanceDiabetes Mellitus, Type 2

Interventions

RosiglitazoneMetformin

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBiguanidesGuanidinesAmidines

Study Officials

  • Pirjo Nuutila, MD, PhD

    Turku University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2015

First Posted

August 18, 2015

Study Start

October 1, 2000

Primary Completion

December 1, 2001

Study Completion

December 1, 2001

Last Updated

August 18, 2015

Record last verified: 2015-08

Locations

FI(3)