MedDataX Logo

Efficacy and Safety of Alogliptin and Metformin Fixed-Dose Combination in Participants With Type 2 Diabetes

NCT ID: NCT01890122

Last Updated: 2016-11-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

647 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the efficacy and safety of alogliptin and metformin fixed-dose combination (FDC) as compared with alogliptin alone or metformin alone on Type 2 Diabetes Mellitus (T2DM).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The drug being tested in this study is a fixed-dose combination tablet of alogliptin and metformin to treat people who have diabetes. This study will look at glycemic control in people who take alogliptin and metformin FDC compared with alogliptin or metformin alone. The study will enroll approximately 640 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the four treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):

* Alogliptin 12.5 mg twice daily (BID)
* Metformin hydrochloride (HCl) 500 mg BID
* Alogliptin 12.5 mg and Metformin HCl 500 mg FDC BID
* Placebo (dummy inactive pill) - this is a tablet/capsule that looks like the study drug but has no active ingredient.

All participants will be asked to take 2 tablets and 1 capsule twice a day at the same time each day throughout the study. All participants will be asked to record any hypoglycemic events in a diary. This multi-center trial will be conducted in China, South Korea, Taiwan and Malaysia. The overall time to participate in this study is 34 weeks. Participants will make 11 visits to the clinic.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Drug therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Metformin HCl 500 mg

Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.

Group Type ACTIVE_COMPARATOR

Metformin HCl

Intervention Type DRUG

Metformin HCl capsules

Alogliptin Placebo

Intervention Type DRUG

Alogliptin placebo-matching tablets

Alogliptin and Metformin FDC Placebo

Intervention Type DRUG

Alogliptin and metformin FDC placebo-matching tablets

Alogliptin 12.5 mg

Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.

Group Type ACTIVE_COMPARATOR

Alogliptin

Intervention Type DRUG

Alogliptin tablets

Metformin Placebo

Intervention Type DRUG

Metformin placebo-matching capsules

Alogliptin and Metformin FDC Placebo

Intervention Type DRUG

Alogliptin and metformin FDC placebo-matching tablets

Alogliptin 12.5 mg + Metformin HCl 500 mg FDC

Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.

Group Type EXPERIMENTAL

Alogliptin and Metformin Fixed-Dose Combination (FDC)

Intervention Type DRUG

Alogliptin and metformin FDC tablets

Alogliptin Placebo

Intervention Type DRUG

Alogliptin placebo-matching tablets

Metformin Placebo

Intervention Type DRUG

Metformin placebo-matching capsules

Placebo

Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.

Group Type PLACEBO_COMPARATOR

Alogliptin Placebo

Intervention Type DRUG

Alogliptin placebo-matching tablets

Metformin Placebo

Intervention Type DRUG

Metformin placebo-matching capsules

Alogliptin and Metformin FDC Placebo

Intervention Type DRUG

Alogliptin and metformin FDC placebo-matching tablets

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Alogliptin

Alogliptin tablets

Intervention Type DRUG

Metformin HCl

Metformin HCl capsules

Intervention Type DRUG

Alogliptin and Metformin Fixed-Dose Combination (FDC)

Alogliptin and metformin FDC tablets

Intervention Type DRUG

Alogliptin Placebo

Alogliptin placebo-matching tablets

Intervention Type DRUG

Metformin Placebo

Metformin placebo-matching capsules

Intervention Type DRUG

Alogliptin and Metformin FDC Placebo

Alogliptin and metformin FDC placebo-matching tablets

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

SYR-322; Nesina Glucophage Kazano

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Capable of understanding and complying with protocol requirements.
2. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
3. Has a historical diagnosis of Type 2 diabetes mellitus (T2DM).
4. Male or female and aged 18 to 75 years, inclusive.
5. Body mass index (BMI) between 20 and 45 kg/m\^2, inclusive.
6. A female of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study.
7. Is experiencing inadequate glycemic control defined as glycosylated hemoglobin (HbA1c) concentration between 7.5% and 10%, inclusive, and has been treated with diet and exercise for at least 2 months prior to Screening. (Exception: a participant who has received any other diabetic therapy for less than 7 days in total within the 2 months prior to the screening, can be included).
8. If male, has a hemoglobin \>12 g/dL (\>120 g/L) at Screening or if female, has a hemoglobin \>10 g/dL (\>100 g/L) at Screening.
9. If male, has a serum creatinine \<1.5 mg/dL at Screening or if female, has a serum creatinine \<1.4 mg/dL at Screening, and estimated glomerular filtration rate (eGFR) \>60 mL/min/1.73 m\^2 based on calculation using the Modification of Diet in Renal Disease (MDRD) at Screening.
10. Willing and able to monitor their own blood glucose concentrations using a home glucose monitor and complete a subject diary.

Exclusion Criteria

1. Participated in another clinical study within 90 days prior to Screening.
2. Received any investigational compound within 30 days prior to Randomization.
3. Received a dipeptidyl peptidase-4 (DPP-4) inhibitor within 3 months prior to screening.
4. History of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening.
5. History of treatment for diabetic gastric paresis, gastric banding, or gastric bypass surgery.
6. History of diabetic ketoacidosis or hyperosmolar non-ketotic coma.
7. Chronic pancreatitis and/or history of acute pancreatitis.
8. Systolic blood pressure \>180 mm Hg and/or diastolic blood pressure \>110 mm Hg at Screening.
9. History of any hemoglobinopathy or diagnosis of chronic anemia.
10. New York Heart Association Class III or IV heart failure. (Participants who are stable at Class I or II and are currently treated, are candidates for the study.)
11. History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within 6 months prior to Screening.
12. History of any cancer, other than squamous cell or basal cell carcinoma of the skin, which has not been in full remission for at least 5 years prior to Screening. Participants with a history of treated cervical intraepithelial neoplasia \[CIN\] I or CIN II are allowed.
13. Significant clinical sign or symptom of hepatopathy, acute or chronic hepatitis, human immunodeficiency virus or alanine aminotransferase (ALT) is 2.5 times above upper limit of normal value.
14. History of angioedema in association with use of angiotensin-converting enzyme inhibitors (ACEI) or angiotensin II receptor blockers (ARB).
15. History of hypersensitivity or allergies to any DPP-4 inhibitor and/or metformin or related compounds.
16. Has used oral or systemically injected glucocorticoids (including intra-articular injection) or has used weight-loss drugs within 2 months prior to Screening. (Inhaled or topical corticosteroids were allowed.)
17. History of alcohol or substance abuse within 2 years prior to Screening.
18. Has used medicine for weight loss within 60 days prior to Screening (such as Xenical, Sibutramine, Phenylpropanolamine or similar nonprescription drugs).
19. History of organ transplantation.
20. Is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
21. Has, in the judgment of the investigator, any major illness or debility that may prohibit the participant from completing the study.
22. If female, is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Medical Director

Role: STUDY_DIRECTOR

Takeda

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beijing, Beijing Municipality, China

Site Status

Fuzhou, Fujian, China

Site Status

Xiamen, Fujian, China

Site Status

Guangzhou, Guangdong, China

Site Status

Nanning, Guangxi, China

Site Status

Guiyang, Guizhou, China

Site Status

Hengshui, Hebei, China

Site Status

Shijiazhuang, Hebei, China

Site Status

Shiyan, Hubei, China

Site Status

Wuhan, Hubei, China

Site Status

Changsha, Hunan, China

Site Status

Yueyang, Hunan, China

Site Status

Changzhou, Jiangsu, China

Site Status

Nanjing, Jiangsu, China

Site Status

Suzhou, Jiangsu, China

Site Status

Nanchang, Jiangxi, China

Site Status

Changchun, Jilin, China

Site Status

Shenyang, Liaoning, China

Site Status

Xi’an, Shanxi, China

Site Status

Chengdu, Sichuan, China

Site Status

Wenzhou, Zhejiang, China

Site Status

Beijing, , China

Site Status

Shanghai, , China

Site Status

Tianjin, , China

Site Status

Johor Bahru, Johor, Malaysia

Site Status

Alor Star, Kedah, Malaysia

Site Status

Alor Star, Kedah Darul Aman, Malaysia

Site Status

Kubang Kerian, Kelantan, Malaysia

Site Status

Putrajaya, Kuala Lumpur, Malaysia

Site Status

Kampung Baharu Nilai, Negeri Sembilan, Malaysia

Site Status

Seremban, Negeri Sembilan, Malaysia

Site Status

Tampin, Negeri Sembilan, Malaysia

Site Status

Bagan Serai, Perak, Malaysia

Site Status

Ipoh, Perak, Malaysia

Site Status

Petaling Jaya, Selangor, Malaysia

Site Status

Shah Alam, Selangor, Malaysia

Site Status

Goyang-si, Gyeonggi-do, South Korea

Site Status

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Suwon, Gyeonggi-do, South Korea

Site Status

Busan, , South Korea

Site Status

Seoul, , South Korea

Site Status

Kaohsiung City, , Taiwan

Site Status

New Taipei City, , Taiwan

Site Status

Taichung, , Taiwan

Site Status

Taipei, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China Malaysia South Korea Taiwan

Related Links

Access external resources that provide additional context or updates about the study.

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203414s000lbl.pdf

The Alogliptin-Metformin Fixed Dose Combination (KAZANO) were approved in the United States (US) on 25 January 2013.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

U1111-1139-0497

Identifier Type: REGISTRY

Identifier Source: secondary_id

NMRR-12-799-12754

Identifier Type: REGISTRY

Identifier Source: secondary_id

CTR20130254

Identifier Type: REGISTRY

Identifier Source: secondary_id

1036022140

Identifier Type: REGISTRY

Identifier Source: secondary_id

SYR-322MET_303

Identifier Type: -

Identifier Source: org_study_id