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

NCT ID: NCT01456130

Last Updated: 2014-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-03-31

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.

Detailed Description

One alogliptin 25 mg tablet was orally administered once daily before breakfast for up to 52 weeks.

The dose of alogliptin was adjusted according to the severity of the participant's renal dysfunction based on serum creatinine (SCr) levels. Participants with moderate renal dysfunction (SCr, >1.4 - ≤2.4 mg/dL for men and >1.2 - ≤ 2.0 mg/dL for women) received alogliptin 12.5 mg tablets.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Alogliptin

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.

Group Type: EXPERIMENTAL

Alogliptin

Intervention Type: DRUG

Alogliptin tablets

Rapid-acting insulin secretagogue

Intervention Type: 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

Interventions

Alogliptin

Alogliptin tablets

Intervention Type: DRUG

Rapid-acting insulin secretagogue

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

Intervention Type: DRUG

Other Intervention Names

SYR-322; Nesina®

Eligibility Criteria

Inclusion Criteria

1. Diagnosed with type 2 diabetes mellitus.

2. Had an HbA1c of ≥ 6.5% and < 10.0% at the start of the observation period (Week -2).

3. 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).

4. 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).

5. 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.

6. 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.

7. Male or female and aged 20 years or older at the time of signing of informed consent.

8. 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.

9. Visited the study site on an outpatient basis during the observation period.

10. Was capable of understanding and complying with protocol requirements in the investigator's or subinvestigator's opinion.

11. Signed and dated the informed consent documents prior to the start of any study procedures.

Exclusion Criteria

1. 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)].

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)].

3. Any serious cardiac disease, serious cerebrovascular disorder, or serious pancreatic or hematological disease (e.g., requiring hospitalization for treatment).

4. Systolic blood pressure of ≥ 180 mmHg or diastolic blood pressure of ≥ 110 mmHg during the observation period.

5. 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).

6. Malignant tumor.

7. History of hypersensitivity or allergies to dipeptidyl-peptidase-4 (DPP-4) inhibitors.

8. A habitual drinker whose daily alcohol consumption was >100 mL on average.

9. A history of drug abuse (defined as any illicit drug use) or alcohol abuse.

10. Required to take excluded medications during the duration of the study.

11. Previously received SYR-322 or Nesina® Tablets in a clinical study or as a therapeutic drug.

12. Received any investigational product (including investigational products for postmarketing clinical studies) within 12 weeks prior to the start of the observation period.

13. Had participated in another clinical study at signing of informed consent.

14. 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.

15. 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.

16. Changed the dosing regimen of the ongoing rapid-acting insulin secretagogue during the observation period.

17. History of hypersensitivity or allergies to rapid-acting insulin secretagogues.

18. Any condition for which Nesina® Tablets, nateglinide, or mitiglinide calcium hydrate was contraindicated as defined in their package inserts.

19. Otherwise ineligible for participation in the study in the investigator's or subinvestigator's opinion.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director, Clinical Science

Role: STUDY_DIRECTOR

Takeda

Locations

Nagoya, Aichi-ken, Japan

Fukuoka, Fukuoka, Japan

Kurume-shi, Fukuoka, Japan

Sapporo, Hokkaido, Japan

Kobe, Hyōgo, Japan

Kagoshima, Kagoshima-ken, Japan

Kumamoto, Kumamoto, Japan

Osaki-shi, Miyagi, Japan

Minou-shi, Osaka, Japan

Osaka, Osaka, Japan

Kamio-shi, Saitama, Japan

Koshigaya-shi, Saitama, Japan

Adachi-ku, Tokyo, Japan

Chuo-ku, Tokyo, Japan

Countries

Japan

Other Identifiers

U1111-1124-8848

Identifier Type: REGISTRY

Identifier Source: secondary_id

JapicCTI-111643

Identifier Type: REGISTRY

Identifier Source: secondary_id

SYR-322/OCT-901

Identifier Type: -

Identifier Source: org_study_id