A Study to Evaluate the Effect of add-on Pioglitazone or Glimepiride in Participants With Type 2 Diabetes Mellitus Inadequately Controlled by Alogliptin and Metformin Therapy (EPIDOTE)
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|ClinicalTrials.gov Identifier: NCT03499704|
Recruitment Status : Not yet recruiting
First Posted : April 17, 2018
Last Update Posted : January 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Drug: SYR-322-4833 Drug: Alogliptin Drug: Metformin Drug: Glimepiride||Phase 4|
The drug being tested in this study is SYR-322-4833/Alogliptin Benzoate and Pioglitazone Hydrochloride FDC. This study will assess the efficacy of pioglitazone or glimepiride in participants with type 2 diabetes mellitus.
The study will enroll approximately 176 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups.
- SYR-322-4833 (15 mg + 25 mg) + Metformin >=500 mg
- Glimepiride 2 mg + Alogliptin 25 mg + Metformin >=500 mg
Based on investigators opinion at Week 12, if participant has HbA1c >=7.5%, dose of pioglitazone and glimepiride can be titrated up to 30 mg and 4 mg respectively.
This multi-center trial will be conducted in Republic of Korea. The overall time to participate in this study is 54 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone 14 days after their last dose of drug for a follow-up assessment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||176 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Randomized, Open-label, Two-arm, Phase 4 Study to Evaluate the Effect of Add-on Pioglitazone or Glimepiride in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled by Alogliptin and Metformin Therapy|
|Estimated Study Start Date :||August 31, 2019|
|Estimated Primary Completion Date :||June 26, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: Pioglitazone + Alogliptin + Metformin (PAM)
SYR-322-4833 (pioglitazone 15 milligram ([mg] and alogliptin 25 mg) fixed dose combination (FDC) tablet, orally once daily and metformin greater than or equal to (>=) 500 mg, tablet, orally, twice a day for up to 52 weeks. At Week 12, if participants has HbA1c >=7.5 percent (%), pioglitazone dose will be titrated up to 30 mg based on investigator's opinion and up-titrated dose will be maintained up to Week 52.
Other Name: Alogliptin Benzoate and Pioglitazone Hydrochloride FDC
Active Comparator: Glimepiride + Alogliptin + Metformin (GAM)
Glimepiride 2 mg, tablet, orally, once daily with alogliptin, tablet, orally, once daily, and metformin tablet, orally, twice a day, for up to Week 52. At Week 12, if participants has HbA1c >=7.5%, glimepiride dose will be titrated up to 4 mg based on investigator's opinion and up-titrated dose will be maintained up to Week 52.
- Mean Change from Baseline in HbA1c at Week 26 [ Time Frame: Baseline and Week 26 ]
- Change from Baseline in Homeostatic Model Assessment of Insulin resistance (HOMA-IR) at Week 52 [ Time Frame: Baseline and Week 52 ]HOMA IR measures insulin resistance based on fasting glucose and insulin measurements: HOMA IR = fasting plasma insulin (micro unit per milliliter [mcU/mL]) * fasting plasma glucose (milligram per deciliter [mg/dL]) / 405. A higher number indicates a greater insulin resistance.
- Mean Change from Baseline in HbA1c at Week 52 [ Time Frame: Baseline and Week 52 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499704
|Contact: Takeda Study Registration Call Centerfirstname.lastname@example.org|
|Study Director:||Medical Director||Takeda|