- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01890122
Efficacy and Safety of Alogliptin and Metformin Fixed-Dose Combination in Participants With Type 2 Diabetes
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Alogliptin and Metformin Fixed Dose Combination, Alogliptin Alone, or Metformin Alone in Subjects With Type 2 Diabetes Mellitus
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Beijing, China
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Shanghai, China
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Tianjin, China
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Beijing
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Beijing, Beijing, China
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Fujian
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Fuzhou, Fujian, China
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Xiamen, Fujian, China
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Guangdong
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Guangzhou, Guangdong, China
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Guangxi
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Nanning, Guangxi, China
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Guizhou
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Guiyang, Guizhou, China
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Hebei
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Hengshui, Hebei, China
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Shijiazhuang, Hebei, China
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Hubei
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Shiyan, Hubei, China
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Wuhan, Hubei, China
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Hunan
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Changsha, Hunan, China
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Yueyang, Hunan, China
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Jiangsu
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Changzhou, Jiangsu, China
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Nanjing, Jiangsu, China
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Suzhou, Jiangsu, China
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Jiangxi
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Nanchang, Jiangxi, China
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Jilin
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Changchun, Jilin, China
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Liaoning
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Shenyang, Liaoning, China
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Shanxi
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Xi'an, Shanxi, China
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Sichuan
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Chengdu, Sichuan, China
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Zhejiang
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Wenzhou, Zhejiang, China
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Busan, Korea, Republic of
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Seoul, Korea, Republic of
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Gyeonggi-do
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Goyang-si, Gyeonggi-do, Korea, Republic of
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Seongnam-si, Gyeonggi-do, Korea, Republic of
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Suwon, Gyeonggi-do, Korea, Republic of
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Johor
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Johor Bahru, Johor, Malaysia
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Kedah
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Alor Setar, Kedah, Malaysia
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Kedah Darul Aman
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Alor Setar, Kedah Darul Aman, Malaysia
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Kelantan
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Kubang Kerian, Kelantan, Malaysia
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Negeri Sembilan
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Nilai, Negeri Sembilan, Malaysia
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Seremban, Negeri Sembilan, Malaysia
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Tampin, Negeri Sembilan, Malaysia
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Perak
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Bagan Serai, Perak, Malaysia
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Ipoh, Perak, Malaysia
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Selangor
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Petaling Jaya, Selangor, Malaysia
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Shah Alam, Selangor, Malaysia
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WIlayah Persekutuan
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Putrajaya, WIlayah Persekutuan, Malaysia
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Kaohsiung, Taiwan
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New Taipei City, Taiwan
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Taichung, Taiwan
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Taipei, Taiwan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Capable of understanding and complying with protocol requirements.
- 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.
- Has a historical diagnosis of Type 2 diabetes mellitus (T2DM).
- Male or female and aged 18 to 75 years, inclusive.
- Body mass index (BMI) between 20 and 45 kg/m^2, inclusive.
- 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.
- 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).
- 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.
- 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.
- Willing and able to monitor their own blood glucose concentrations using a home glucose monitor and complete a subject diary.
Exclusion Criteria:
- Participated in another clinical study within 90 days prior to Screening.
- Received any investigational compound within 30 days prior to Randomization.
- Received a dipeptidyl peptidase-4 (DPP-4) inhibitor within 3 months prior to screening.
- History of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening.
- History of treatment for diabetic gastric paresis, gastric banding, or gastric bypass surgery.
- History of diabetic ketoacidosis or hyperosmolar non-ketotic coma.
- Chronic pancreatitis and/or history of acute pancreatitis.
- Systolic blood pressure >180 mm Hg and/or diastolic blood pressure >110 mm Hg at Screening.
- History of any hemoglobinopathy or diagnosis of chronic anemia.
- 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.)
- History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within 6 months prior to Screening.
- 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.
- 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.
- History of angioedema in association with use of angiotensin-converting enzyme inhibitors (ACEI) or angiotensin II receptor blockers (ARB).
- History of hypersensitivity or allergies to any DPP-4 inhibitor and/or metformin or related compounds.
- 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.)
- History of alcohol or substance abuse within 2 years prior to Screening.
- Has used medicine for weight loss within 60 days prior to Screening (such as Xenical, Sibutramine, Phenylpropanolamine or similar nonprescription drugs).
- History of organ transplantation.
- 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.
- Has, in the judgment of the investigator, any major illness or debility that may prohibit the participant from completing the study.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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ACTIVE_COMPARATOR: 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.
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Metformin HCl capsules
Other Names:
Alogliptin placebo-matching tablets
Alogliptin and metformin FDC placebo-matching tablets
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ACTIVE_COMPARATOR: 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.
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Alogliptin tablets
Other Names:
Alogliptin and metformin FDC placebo-matching tablets
Metformin placebo-matching capsules
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EXPERIMENTAL: 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.
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Alogliptin placebo-matching tablets
Metformin placebo-matching capsules
Alogliptin and metformin FDC tablets
Other Names:
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PLACEBO_COMPARATOR: 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.
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Alogliptin placebo-matching tablets
Alogliptin and metformin FDC placebo-matching tablets
Metformin placebo-matching capsules
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 (or Early Termination)
Time Frame: Baseline and Week 26 (or Early termination)
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The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 26 or early termination relative to baseline.
Negative change indicates better glycemic control.
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Baseline and Week 26 (or Early termination)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline in HbA1c at Weeks 4, 8, 12, 16 and 20
Time Frame: Baseline and Weeks 4, 8, 12, 16 and 20
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The change in the value of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Weeks 4, 8, 12, 16 and 20 relative to baseline.
Negative change indicates better glycemic control.
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Baseline and Weeks 4, 8, 12, 16 and 20
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Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 8, 12, 16, 20 and 26
Time Frame: Baseline and Weeks 4, 8, 12, 16, 20 and 26
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The change between the FPG value collected at Weeks 4, 8, 12, 16, 20 and 26 relative to baseline.
Negative change indicates better glycemic control.
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Baseline and Weeks 4, 8, 12, 16, 20 and 26
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Time to Hyperglycemic Rescue Event
Time Frame: From the date of randomization through Week 26
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Rescue is defined as meeting one of the following criteria, confirmed by a second sample drawn within 7 days of first sample: After >1 week of treatment but prior to Week 4 visit: A single FPG ≥275 mg/dL (≥15.27
mmol/L); From the Week 4 but prior to the Week 8 visit: A single FPG ≥250 mg/dL (≥13.88 mmol/L); From the Week 8 visit but prior to the Week 12 visit: A single FPG ≥225 mg/dL (≥12.49
mmol/L); From the Week 12 visit through the end-of-treatment visit (week 26): HbA1c ≥8.5% and ≤0.5% reduction in HbA1c from baseline.
Time to hyperglycemic rescue was censored if the participant did not experience a hyperglycemic rescue event.
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From the date of randomization through Week 26
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Percentage of Participants Requiring Hyperglycemic Rescue
Time Frame: Baseline up to Week 26
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Rescue is defined as meeting one of the following criteria, confirmed by a second sample drawn within 7 days of first sample: After >1 week of treatment but prior to Week 4 visit: A single FPG ≥275 mg/dL (≥15.27
mmol/L); From the Week 4 but prior to the Week 8 visit: A single FPG ≥250 mg/dL (≥13.88 mmol/L); From the Week 8 visit but prior to the Week 12 visit: A single FPG ≥225 mg/dL (≥12.49
mmol/L); From the Week 12 visit through the end-of-treatment visit (week 26): HbA1c ≥8.5% and ≤0.5% reduction in HbA1c from baseline.
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Baseline up to Week 26
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Percentage of Participants With Marked Hyperglycemia
Time Frame: Baseline up to Week 26
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Marked hyperglycemia is defined as FPG level ≥200 mg/dL (11.1 mmol/L).
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Baseline up to Week 26
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Change From Baseline in Body Weight at Weeks 12 and 26
Time Frame: Baseline and Weeks 12 and 26
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Change in participant's body weight at Weeks 12 and 26 relative to baseline.
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Baseline and Weeks 12 and 26
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Percentage of Participants With Glycosylated Hemoglobin ≤6.5%
Time Frame: Week 26
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Clinical response at Week 26 will be assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) ≤6.5%.
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Week 26
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Percentage of Participants With Glycosylated Hemoglobin ≤7.0%
Time Frame: Week 26
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Clinical response at Week 26 will be assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) ≤7%.
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Week 26
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Percentage of Participants With Glycosylated Hemoglobin ≤7.5%
Time Frame: Week 26
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Clinical response at Week 26 will be assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) ≤7.5%.
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Week 26
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Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥0.5%
Time Frame: Baseline and Week 26
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Clinical response at Week 26 will be assessed by the percentage of participants with a decrease from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) of ≥0.5%.
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Baseline and Week 26
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Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥1.0%
Time Frame: Baseline and Week 26
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Clinical response at Week 26 will be assessed by the percentage of participants with a decrease from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) of ≥1.0%.
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Baseline and Week 26
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Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥1.5%
Time Frame: Baseline and Week 26
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Clinical response at Week 26 will be assessed by the percentage of participants with a decrease from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) of ≥1.5%.
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Baseline and Week 26
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Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥2.0%
Time Frame: Baseline and Week 26
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Clinical response at Week 26 will be assessed by the percentage of participants with a decrease from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) of ≥2.0%.
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Baseline and Week 26
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Incretins
- Dipeptidyl-Peptidase IV Inhibitors
- Metformin
- Alogliptin
Other Study ID Numbers
- SYR-322MET_303
- U1111-1139-0497 (REGISTRY: WHO)
- NMRR-12-799-12754 (REGISTRY: NMRR)
- CTR20130254 (REGISTRY: SFDA CTR)
- 1036022140 (REGISTRY: TCTIN)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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