Pioglitazone vs. Insulin Glargine in the Treatment of Secondary Drug Failure in Type 2 Diabetes

Skane University Hospital

Status and phase: Completed; Phase 4

Conditions: Secondary Drug Failure; Type 2 Diabetes

Treatments: Drug: pioglitazone; Drug: insulin glargine

Study type: Interventional

Funder types: Other

Identifiers

NCT00609856

0

Dnr 111/2004

Details and patient eligibility

About

Pioglitazone and insulin glargine are equally effective in achieving glycemic control in secondary drug failure of type 2 diabetes but the mechanisms of actions are different.

Full description

The present study was undertaken to assess differences in how insulin glargine vs. pioglitazone affect:

• Beta-cell function as measured by proinsulin/insulin, homeostasis model assessment for insulin secretion (HOMA β-cell) and glucagon stimulated C-peptide test
• Insulin sensitivity as measured by adiponectin, homeostasis model assessment for insulin resistance (HOMA-IR) and insulin tolerance test and
• Surrogate markers of cardiovascular disease as measured by BNP, NT-pro BNP and plasma lipid profile as add-on therapy in patients with T2D and secondary drug failure. The patients' satisfaction with each treatment was also surveyed.

Enrollment: 36 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• type 2 diabetes
• inadequately controlled on 50% of maximal-dose of an insulin secretagogue and metformin

Exclusion criteria

• heart failure (NYHA II-IV)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

1

Active Comparator group

Description:

Pioglitazone

Treatment:

Drug: pioglitazone

2

Active Comparator group

Description:

Insulin glargine

Treatment:

Drug: insulin glargine