Efficacy and Safety of Treatment With Balaglitazone in Type 2 Diabetes Patients on Stable Insulin Therapy - Full Text View

Sponsored by:	Rheoscience A/S
Information provided by:	Rheoscience A/S
ClinicalTrials.gov Identifier:	NCT00515632

Purpose

Type 2 diabetes mellitus is a metabolic disorder that is primarily characterized by insulin resistance, relative insulin deficiency, and hyperglycemia. People with type 2 diabetes are at high risk of many serious diabetic complications, including cardiovascular disease, blindness, nerve damage and kidney damage. Balaglitazone is a thiazolidinedione derivative that is being developed as an oral anti-diabetic drug to improve blood glucose control in patients with type 2 diabetes. The purpose of this study is to assess if additional treatment with balaglitazone in patients with type 2 diabetes on stable insulin treatment will improve blood glucose control and decrease the daily insulin dose compared to placebo, but with less impact on weight gain and oedema than pioglitazone (Actos®) 45 mg.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Balaglitazone	Phase III

MedlinePlus related topics: Diabetes Edema

Drug Information available for: Insulin Pioglitazone Pioglitazone hydrochloride Dextrose Balaglitazone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Parallel-Group, Placebo and Active Comparator (Pioglitazone)-Controlled Clinical Study to Determine the Efficacy and Safety of Balaglitazone in Patients With Type 2 Diabetes on Stable Insulin Therapy

Further study details as provided by Rheoscience A/S:

Primary Outcome Measures:

HbA1c, fasting plasma glucose and 7-point plasma glucose profiles, weight gain, lower leg oedema and safety parameters. [ Time Frame: baseline, 4, 8, 12, 17, 21 and 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Waist and hip circumferences, plasmaNT-proBNP, ECG, body composition as measured by DXA, blood lipid profiles, plasma insulin [ Time Frame: baseline and 26 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	400
Study Start Date:	July 2007
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Intervention Details:

One arm balaglitazone 10mg, one arm balaglitazone 20mg, one arm placebo, one arm pioglitazone (Actos®) 45mg, orally taken once daily.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 diabetes mellitus, being diagnosed according to the 1999 WHO criteria for at least 3 months
Age ≥ 18 years
BMI ≥ 25.0 kg/m2
HbA1c ≥ 7.0 %
Treatment with insulin with stable dose of at least 30 U/day (± 4 U/day), for at least 75 days

Exclusion Criteria:

Prior or current use of any PPAR-γ agonist
Recent use (< 3 months) of an investigational drug
Pre-existing medical condition judged to preclude safe participation in the study
Contraindication/intolerance to study medication
Use of any drug which in the Investigator's opinion could interfere with the glucose level (e.g. systemic corticosteroids)
Diagnosed or receiving medication for heart failure, NYHA I to IV
Hospitalisation for a major CV event in the last 3 months, scheduled major CV intervention
Uncontrolled treated/untreated systolic blood pressure >180 mmHg and/or diastolic blood pressure > 95 mmHg
Known diabetic macular oedema
Hematuria
Serum creatinine >130 μmol/l
ALT, AST, total bilirubin or alkaline phosphatase ≥ 2.5 times the upper limit of normal
Haemoglobin significantly (in the Investigators opinion, but not more than 1 mmol/L) below the lower limit of normal or haemoglobinopathy interfering with valid HbA1c assay
Pregnancy, breast feeding or planning pregnancy or not using adequate contraceptive methods (adequate contraceptive measures are an intrauterine device or oral contraceptives)
Mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation
Abuse of alcohol or drugs, or presence of any condition that in the Investigators opinion may lead to poor adherence to study protocols
Cancer or any clinically significant disease or disorder, except for conditions associated to the type 2 diabetes, which in the Investigator's opinion could interfere with the results of the trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00515632

Contacts

Contact: Jesper Prior Larsen

+45 4454 7736

jpl@nordicbioscience.com

Locations

Denmark
Multi-center	Recruiting
Copenhagen, Denmark
Principal Investigator: Hans Perrild, MD

Sponsors and Collaborators

Rheoscience A/S

Investigators

Study Director:

Ole L Svendsen, MD

Rheoscience A/S

More Information

Responsible Party:	Rheoscience A/S ( Bente Juel Riis, MD )
Study ID Numbers:	DRF2593-307, EudraCT No. 2007-002088-29
Study First Received:	August 13, 2007
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00515632
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by Rheoscience A/S:

Type 2 diabetes mellitus on Stable insulin therapy
Balaglitazone
Pioglitazone (Actos®)
HbA1c

Weight gain
Oedema
Fasting blood glucose

Study placed in the following topic categories:

Body Weight
Metabolic Diseases
Pioglitazone
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Edema
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Weight Gain
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009