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

NCT02081599 | Completed Phase 4 Results

• 1 other identifier: 3000-A15
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

insulin resistance

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in HbA1c

  The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 16. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.

  at Week 0 and Week 16

Secondary Outcomes (3)

• Change From Baseline in Fasting Plasma Glucose

  at Week 0 and Week 16

• Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose

  0, 0.5, 1, 2 hours post-dose at Week 0 and Week 16

• Change From Baseline in 2-hour Postprandial Plasma Glucose

  at Week 0 and Week 16

Study Arms (2)

Teneli (Teneligliptin) /Teneli + insulin

EXPERIMENTAL

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

Drug: Teneli (Teneligliptin); Drug: Insulin

Placebo/Teneli (Teneligliptin) + insulin

PLACEBO COMPARATOR

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

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

Interventions

Teneli (Teneligliptin) DRUG

Placebo/Teneli (Teneligliptin) + insulin; Teneli (Teneligliptin) /Teneli + insulin

Placebo DRUG

Placebo/Teneli (Teneligliptin) + insulin

Insulin DRUG

Placebo/Teneli (Teneligliptin) + insulin; Teneli (Teneligliptin) /Teneli + insulin

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (1)

Investigational site

Chuo-ku, Tokyo, Japan

Location

Related Publications (1)

• Kadowaki T, Kondo K, Sasaki N, Miyayama K, Yokota S, Terata R, Gouda M. Efficacy and safety of teneligliptin add-on to insulin monotherapy in Japanese patients with type 2 diabetes mellitus: a 16-week, randomized, double-blind, placebo-controlled trial with an open-label period. Expert Opin Pharmacother. 2017 Sep;18(13):1291-1300. doi: 10.1080/14656566.2017.1359259. Epub 2017 Aug 10.

  PMID: 28741385 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Interventions

3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine; Insulin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Clinical Trials, Information Desk
• Organization: Tanabe Pharma Corporation

cti-inq-ml.JP@ml.tanabe-pharma.com

Study Officials

• Takashi Kadowaki, Professor

  Tokyo University

  STUDY DIRECTOR

• Kazuoki Kondo, MD

  Tanabe Pharma Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2014
• First Posted: March 7, 2014
• Study Start: January 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 2, 2026
• Results First Posted: January 5, 2017

Record last verified: 2025-12

Locations

JP (1)