Efficacy and Safety Study of Teneligliptin (MP-513) in Combination With Insulin in Patients With Type 2 Diabetes

Tanabe Pharma Corporation

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Insulin; Drug: Teneli (Teneligliptin); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02081599

3000-A15

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of Teneligliptin in combination with Insulin in patients with type 2 Diabetes for 16 weeks administration and to evaluate the safety and efficacy of Teneligliptin in combination with Insulin with an extension treatment for up to 52 weeks.

Enrollment: 148 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who has been receiving a stable dose and regimen of insulin over 12 weeks before administration of investigational drug
• Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
• Patients whose HbA1c is between 7.5% and 10.5%
• Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug.

Exclusion criteria

• Patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (Cushing disease, acromegaly, etc)
• Patients who are accepting treatments of arrhythmias
• Patients with serious diabetic complications
• Patients who are the excessive alcohol addicts
• Patients with severe hepatic disorder or severe renal disorder.
• Patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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148 participants in 2 patient groups, including a placebo group

Teneli (Teneligliptin) /Teneli + insulin

Experimental group

Description:

Teneligliptin for 16 weeks (double-blind period) followed by teneligliptin for an additional 36 weeks (open-label period) in combination with insulin.

Treatment:

Drug: Teneli (Teneligliptin)

Drug: Insulin

Placebo/Teneli (Teneligliptin) + insulin

Placebo Comparator group

Description:

Placebo for 16 weeks (double-blind period) followed by teneligliptin for an additional 36 weeks (open-label period) in combination with insulin.

Treatment:

Drug: Placebo

Drug: Teneli (Teneligliptin)

Drug: Insulin