Efficacy and safety of the PPARγ 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

Kim Henriksen; Inger Byrjalsen; Per Qvist; Henning Beck-Nielsen; Gitte Hansen; Bente J Riis; Hans Perrild; Ole Lander Svendsen; Jeppe Gram; Morten A Karsdal; Claus Christiansen; BALLET Trial Investigators

doi:10.1002/dmrr.1187

Efficacy and safety of the PPARγ 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

Kim Henriksen
, Inger Byrjalsen
, Per Qvist
, Henning Beck-Nielsen
, Gitte Hansen
, Bente J Riis
, Hans Perrild
, Ole Lander Svendsen
, Jeppe Gram
, Morten A Karsdal
, Claus Christiansen
, BALLET Trial Investigators

Department of Endocrinology

62 Citations (Scopus)

Abstract

Treatment of patients with perioxisome proliferator-activated receptor-γ full agonists are associated with weight gain, heart failure, peripheral oedema, and bone loss. However, the safety of partial perioxisome proliferator-activated receptor-γ agonists has not been established in a clinical trial. The BALaglitazone glucose Lowering Efficacy Trial aimed to establish the glucose-lowering effects and safety parameters of the perioxisome proliferator-activated receptor-γ partial agonist balaglitazone in diabetic patients on stable insulin therapy.

Original language	English
Journal	Diabetes - Metabolism: Research and Reviews (Print Edition)
Volume	27
Issue number	4
Pages (from-to)	392-401
Number of pages	10
ISSN	1520-7552
DOIs	https://doi.org/10.1002/dmrr.1187
Publication status	Published - 2011

Keywords

Aged
Blood Glucose
Body Composition
Bone Density
Diabetes Mellitus, Type 2
Dose-Response Relationship, Drug
Double-Blind Method
Drug Therapy, Combination
Female
Hemoglobin A, Glycosylated
Humans
Hypoglycemic Agents
Insulin
Male
Middle Aged
PPAR gamma
Quinazolines
Thiazolidinediones
Water-Electrolyte Balance
Weight Gain

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10.1002/dmrr.1187

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Henriksen, K., Byrjalsen, I., Qvist, P., Beck-Nielsen, H., Hansen, G., Riis, B. J., Perrild, H., Svendsen, O. L., Gram, J., Karsdal, M. A., Christiansen, C., & BALLET Trial Investigators (2011). Efficacy and safety of the PPARγ 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 - Metabolism: Research and Reviews (Print Edition), 27(4), 392-401. https://doi.org/10.1002/dmrr.1187

Efficacy and safety of the PPARγ 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. / Henriksen, Kim; Byrjalsen, Inger; Qvist, Per et al.
In: Diabetes - Metabolism: Research and Reviews (Print Edition), Vol. 27, No. 4, 2011, p. 392-401.

Research output: Contribution to journal › Journal article › Research › peer-review

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 2011, 'Efficacy and safety of the PPARγ 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 - Metabolism: Research and Reviews (Print Edition), vol. 27, no. 4, pp. 392-401. https://doi.org/10.1002/dmrr.1187

Henriksen K, Byrjalsen I, Qvist P, Beck-Nielsen H, Hansen G, Riis BJ et al. Efficacy and safety of the PPARγ 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 - Metabolism: Research and Reviews (Print Edition). 2011;27(4):392-401. doi: 10.1002/dmrr.1187

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title = "Efficacy and safety of the PPARγ 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",

abstract = "Treatment of patients with perioxisome proliferator-activated receptor-γ full agonists are associated with weight gain, heart failure, peripheral oedema, and bone loss. However, the safety of partial perioxisome proliferator-activated receptor-γ agonists has not been established in a clinical trial. The BALaglitazone glucose Lowering Efficacy Trial aimed to establish the glucose-lowering effects and safety parameters of the perioxisome proliferator-activated receptor-γ partial agonist balaglitazone in diabetic patients on stable insulin therapy.",

keywords = "Aged, Blood Glucose, Body Composition, Bone Density, Diabetes Mellitus, Type 2, Dose-Response Relationship, Drug, Double-Blind Method, Drug Therapy, Combination, Female, Hemoglobin A, Glycosylated, Humans, Hypoglycemic Agents, Insulin, Male, Middle Aged, PPAR gamma, Quinazolines, Thiazolidinediones, Water-Electrolyte Balance, Weight Gain",

author = "Kim Henriksen and Inger Byrjalsen and Per Qvist and Henning Beck-Nielsen and Gitte Hansen and Riis, \{Bente J\} and Hans Perrild and Svendsen, \{Ole Lander\} and Jeppe Gram and Karsdal, \{Morten A\} and Claus Christiansen and \{BALLET Trial Investigators\}",

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