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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
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this study is to compare the efficacy of pioglitazone plus alogliptin plus metformin with glimepiride plus alogliptin plus metformin on glycosylated haemoglobin (HbA1c) change from baseline to Week 26.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: SYR-322-4833 Drug: Alogliptin Drug: Metformin Drug: Glimepiride Phase 4

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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.
Drug: SYR-322-4833
SYR-322-4833 tablets.
Other Name: Alogliptin Benzoate and Pioglitazone Hydrochloride FDC

Drug: Metformin
Metformin tablets.

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.
Drug: Alogliptin
Alogliptin tablets.

Drug: Metformin
Metformin tablets.

Drug: Glimepiride
Glimepiride tablets.




Primary Outcome Measures :
  1. Mean Change from Baseline in HbA1c at Week 26 [ Time Frame: Baseline and Week 26 ]

Secondary Outcome Measures :
  1. 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.

  2. Mean Change from Baseline in HbA1c at Week 52 [ Time Frame: Baseline and Week 52 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Has a historical diagnosis of type 2 diabetes.
  2. Has a body mass index (BMI) of approximately 20 to 30 kilogram per square meter (kg/m^2).
  3. Has been receiving a stable dose of alogliptin + metformin therapy with diet and exercise for >=3 months prior to randomization.
  4. Has an HbA1c value approximately 7.5 to 10% inclusively at baseline.

Exclusion Criteria:

  1. Has received thiazolidinedione (TZD) and sulfonylurea (SU) within 6 months prior to randomization.
  2. Has type 1 diabetes, diabetic ketoacidosis, diabetic coma or diabetic pre-coma.
  3. Has genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder, etc.
  4. Has a history of alcohol abuse within 2 years prior to randomization.

Information from the National Library of Medicine

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


Contacts
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Contact: Takeda Study Registration Call Center +1-877-825-3327 medicalinformation@tpna.com

Sponsors and Collaborators
Takeda
Investigators
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Study Director: Medical Director Takeda

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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03499704     History of Changes
Other Study ID Numbers: Alogliptin-Pio-4001
U1111-1207-8037 ( Other Identifier: World Health Organization )
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Takeda:
Drug therapy

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Pioglitazone
Glimepiride
Alogliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action