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A Multicentre, Randomized, Double-blind, Placebo-controlled, phase III study to evaluate the efficacy and safety of Pioglitazone co-administration in patients with type II diabetes with insufficient glycemic control with Metformin and Empagliflozin combination therapy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508924-36-00
Acronym
CT-L03-301
Enrollment
224
Registered
2024-05-27
Start date
2024-08-20
Completion date
Unknown
Last updated
2025-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus (T2DM)

Brief summary

Change from Baseline in HbA1c at Week 24 of the Treatment

Detailed description

Change from Baseline in HbA1c at Week 12 of the Treatment, Change from Baseline in fasting plasma glucose (FPG) at Week 12 and 24 of the Treatment, Proportion (%) of subjects who achieved HbA1c < 6.5% at Week 24 of the Treatment, Proportion (%) of subjects who achieved HbA1c < 7.0% at Week 24 of the Treatment, Change from Baseline in lipid profile (total cholesterol, LDL-C, HDL-C, and TG) levels at Week 12 and 24 of the Treatment, Change from Baseline in insulin resistance (HOMA-IR) and insulin secretion ability (HOMA-β) at Week 12 and 24 of the Treatment, Change from Baseline in liver function indicators (AST, ALT) at Week 12 and 24 of the Treatment, Proportion (%) of subjects who received a rescue medication at Week 12 and 24 of the Treatment, Change from Baseline in body weight at Week 12 and 24 of the Treatment, Change from Baseline in blood pressure (SBP, DBP) at Week 12 and 24 of the Treatment, Change from Baseline in heart rate at Week 12 and 24 of the Treatment, Change from Baseline in waist circumference at Week 12 and 24 of the Treatment

Interventions

DRUGMETFORMIN HYDROCHLORIDE
DRUGPioglitazone
DRUGGLIPIZIDE
DRUGGLIQUIDONE
DRUGGLIMEPIRIDE
DRUGGLICLAZIDE
DRUGEMPAGLIFLOZIN
DRUGPlacebo for Actos 15 mg tablets

Sponsors

Celltrion Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change from Baseline in HbA1c at Week 24 of the Treatment

Secondary

MeasureTime frame
Change from Baseline in HbA1c at Week 12 of the Treatment, Change from Baseline in fasting plasma glucose (FPG) at Week 12 and 24 of the Treatment, Proportion (%) of subjects who achieved HbA1c < 6.5% at Week 24 of the Treatment, Proportion (%) of subjects who achieved HbA1c < 7.0% at Week 24 of the Treatment, Change from Baseline in lipid profile (total cholesterol, LDL-C, HDL-C, and TG) levels at Week 12 and 24 of the Treatment, Change from Baseline in insulin resistance (HOMA-IR) and insulin secretion ability (HOMA-β) at Week 12 and 24 of the Treatment, Change from Baseline in liver function indicators (AST, ALT) at Week 12 and 24 of the Treatment, Proportion (%) of subjects who received a rescue medication at Week 12 and 24 of the Treatment, Change from Baseline in body weight at Week 12 and 24 of the Treatment, Change from Baseline in blood pressure (SBP, DBP) at Week 12 and 24 of the Treatment, Change from Baseline in heart rate at Week 12 and 24 of the Treatment, Change from Bas

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026