Long-term Study of Alogliptin as an Add-on to Rapid-Acting Insulin Secretagogues in Type 2 Diabetes

NCT01456130 | Completed Phase 3 Results

• 3 other identifiers: SYR-322/OCT-901U1111-1124-8848JapicCTI-111643
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 14

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of alogliptin as an add-on to a rapid-acting insulin secretagogue (medicine that stimulates insulin release) in type 2 diabetic patients with inadequate blood glucose control despite treatment with a rapid-acting insulin secretagogue as well as diet and exercise therapies.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  An TEAE is any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have a causal relationship with this treatment. A serious TEAE is defined as any untoward medical occurrence that resulted in death, was life threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability or incapacity, led to a congenital anomaly/birth defect or was an important medical event that may have required intervention to prevent any of items above.

  52 Weeks

Secondary Outcomes (3)

• Change From Baseline in Glycosylated Hemoglobin (HbA1c)

  Baseline and Week 52

• Percentage of Participants With a Clinical Response

  Week 52

• Change From Baseline in Fasting Glucose

  Baseline and Week 52

Study Arms (1)

Alogliptin

EXPERIMENTAL

Alogliptin 25 mg (or 12.5 mg for participants with moderate renal dysfunction) tablets, orally once daily and a rapid-acting insulin secretagogue as prescribed by the Investigator for up to 52 weeks.

Drug: Alogliptin; Drug: Rapid-acting insulin secretagogue

Interventions

Alogliptin DRUG

Alogliptin tablets

Also known as: SYR-322, Nesina®

Alogliptin

Rapid-acting insulin secretagogue DRUG

Either of the following commercially available rapid-acting insulin secretagogues as prescribed by the Investigator: (i) Nateglinide: Dose: 30 mg tablet or 90 mg tablet (ii) Mitiglinide calcium hydrate: Dose: 5 mg tablet or 10 mg tablet

Alogliptin

Eligibility Criteria

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

You may qualify if:

• Diagnosed with type 2 diabetes mellitus.
• Had an HbA1c of ≥ 6.5% and \< 10.0% at the start of the observation period (Week -2).
• Had been receiving specific diet and exercise (if applicable) therapies since at least 10 weeks prior to the start of the observation period (Week -2).
• Had been receiving basic diabetes treatment with a rapid-acting insulin secretagogue (nateglinide or mitiglinide calcium hydrate) alone using a stable dosage regimen since at least 10 weeks prior to the start of the observation period (Week -2).
• Was suitable for combination therapy of either of the above rapid-acting insulin secretagogues (nateglinide or mitiglinide calcium hydrate) and another antidiabetic drug at the start of the observation period (Week -2) in the investigator's or subinvestigator's opinion.
• Participants complicated by hypertension had stable blood pressure control and needed neither dose adjustment of the ongoing antihypertensive (including discontinuation and interruption) nor additional use of another antihypertensive throughout the duration of the study in the investigator's or subinvestigator's opinion.
• Male or female and aged 20 years or older at the time of signing of informed consent.
• If female, and of child-bearing potential and sexually active with a nonsterilized male partner agreed to use adequate contraception routinely from signing of informed consent throughout the duration of the study.
• Visited the study site on an outpatient basis during the observation period.
• Was capable of understanding and complying with protocol requirements in the investigator's or subinvestigator's opinion.
• Signed and dated the informed consent documents prior to the start of any study procedures.

You may not qualify if:

• Severe renal dysfunction or end-stage renal disease \[e.g., a serum creatinine (SCr) level of \>2.4 mg/dL (men) or \>2.0 mg/dL (women) at the start of the observation period (Week -2)\].
• Obvious clinical manifestations of hepatic impairment \[e.g., an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value of ≥ 2.5 times the upper limit of normal at the start of the observation period (Week -2)\].
• Any serious cardiac disease, serious cerebrovascular disorder, or serious pancreatic or hematological disease (e.g., requiring hospitalization for treatment).
• Systolic blood pressure of ≥ 180 mmHg or diastolic blood pressure of ≥ 110 mmHg during the observation period.
• A condition requiring insulin for blood glucose control (e.g., a patient with severe ketosis, diabetic coma or precoma, type 1 diabetes mellitus, severe infection, a pre- or post-operative condition, or serious trauma).
• Malignant tumor.
• History of hypersensitivity or allergies to dipeptidyl-peptidase-4 (DPP-4) inhibitors.
• A habitual drinker whose daily alcohol consumption was \>100 mL on average.
• A history of drug abuse (defined as any illicit drug use) or alcohol abuse.
• Required to take excluded medications during the duration of the study.
• Previously received SYR-322 or Nesina® Tablets in a clinical study or as a therapeutic drug.
• Received any investigational product (including investigational products for postmarketing clinical studies) within 12 weeks prior to the start of the observation period.
• Had participated in another clinical study at signing of informed consent.
• If female, was pregnant or lactating, or intended to become pregnant between signing of informed consent and 1 month after the end of the study; or intended to donate ova during such time period.
• A study site employee, an immediate family member of a study site employee or in a dependent relationship with a study site employee who was involved in the conduct of this study (e.g., spouse, parent, child, sibling), or might consent under duress.

Sponsors & Collaborators

• Takeda: lead

Study Sites (14)

Unknown Facility

Nagoya, Aichi-ken, Japan

Location

Unknown Facility

Fukuoka, Fukuoka, Japan

Location

Unknown Facility

Kurume-shi, Fukuoka, Japan

Location

Unknown Facility

Sapporo, Hokkaido, Japan

Location

Unknown Facility

Kobe, Hyōgo, Japan

Location

Unknown Facility

Kagoshima, Kagoshima-ken, Japan

Location

Unknown Facility

Kumamoto, Kumamoto, Japan

Location

Unknown Facility

Osaki-shi, Miyagi, Japan

Location

Unknown Facility

Minou-shi, Osaka, Japan

Location

Unknown Facility

Osaka, Osaka, Japan

Location

Unknown Facility

Kamio-shi, Saitama, Japan

Location

Unknown Facility

Koshigaya-shi, Saitama, Japan

Location

Unknown Facility

Adachi-ku, Tokyo, Japan

Location

Unknown Facility

Chuo-ku, Tokyo, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

alogliptin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Medical Director, Clinical Science
• Organization: Takeda

clinicaltrialregistry@tpna.com

800-778-2860

Study Officials

• Medical Director, Clinical Science

  Takeda

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2011
• First Posted: October 20, 2011
• Study Start: November 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: April 21, 2014
• Results First Posted: April 21, 2014

Record last verified: 2014-03

Locations

JP (14)