Back to results

Efficacy and Safety of Treatment With Balaglitazone in Type 2 Diabetes Patients on Stable Insulin Therapy (BALLET)

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 3

Locations

Denmark

Study Type

Interventional

Intervention

Balaglitazone

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Type 2 diabetes mellitus on Stable insulin therapy, Balaglitazone, Pioglitazone (Actos®), HbA1c, Weight gain, Oedema, Fasting blood glucose

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Multi-center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Balaglitazone 10 mg per day

Balaglitazone 20 mg per day

Pioglitazone 45 mg per day

Placebo

Arm Description

Outcomes

Primary Outcome Measures

HbA1c, fasting plasma glucose and 7-point plasma glucose profiles, weight gain, lower leg oedema and safety parameters.

Secondary Outcome Measures

Waist and hip circumferences, plasmaNT-proBNP, ECG, body composition as measured by DXA, blood lipid profiles, plasma insulin

Full Information

NCT ID

NCT00515632

First Posted

August 13, 2007

Last Updated

July 22, 2010

Sponsor

Rheoscience A/S

1. Study Identification

Unique Protocol Identification Number

NCT00515632

Brief Title

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

Acronym

BALLET

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2010

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Rheoscience A/S

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetes mellitus on Stable insulin therapy, Balaglitazone, Pioglitazone (Actos®), HbA1c, Weight gain, Oedema, Fasting blood glucose

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

409 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Balaglitazone 10 mg per day

Arm Type

Experimental

Arm Title

Balaglitazone 20 mg per day

Arm Type

Experimental

Arm Title

Pioglitazone 45 mg per day

Arm Type

Active Comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Balaglitazone

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Waist and hip circumferences, plasmaNT-proBNP, ECG, body composition as measured by DXA, blood lipid profiles, plasma insulin

Time Frame

baseline and 26 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bente J Riis, MD

Organizational Affiliation

Nordic Bioscience Clinical Studies A/S

Official's Role

Study Director

Facility Information:

Facility Name

Multi-center

City

Copenhagen

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

21328517

Citation

Henriksen K, Byrjalsen I, Qvist P, Beck-Nielsen H, Hansen G, Riis BJ, Perrild H, Svendsen OL, Gram J, Karsdal MA, Christiansen C; BALLET Trial Investigators. Efficacy and safety of the PPARgamma partial agonist balaglitazone compared with pioglitazone and placebo: a phase III, randomized, parallel-group study in patients with type 2 diabetes on stable insulin therapy. Diabetes Metab Res Rev. 2011 May;27(4):392-401. doi: 10.1002/dmrr.1187.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs