Diabetes MellitusPhase 3NCT01890122
Efficacy and Safety of Alogliptin and Metformin Fixed-Dose Combination in Participants With Type 2 Diabetes
A Phase 3 study testing Alogliptin, Metformin HCl and Alogliptin and Metformin Fixed-Dose Combination (FDC) in people with Diabetes Mellitus, run by Takeda at 45 sites in 4 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Alogliptin, Metformin HCl and Alogliptin and Metformin Fixed-Dose Combination (FDC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 647 participants
- Where
- 45 sitesin 4 countries
- Study dates
- Sep 2013to Oct 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Show all 22Show fewer
- 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.
Trial locations and contacts
45 sites in 4 countries.
45 sites in 4 countries
China24 sites
Study site
Beijing, Beijing Municipality
Study site
Beijing
Study site
Changchun, Jilin
Study site
Changsha, Hunan
Study site
Changzhou, Jiangsu
Study site
Chengdu, Sichuan
Study site
Fuzhou, Fujian
Study site
Guangzhou, Guangdong
Study site
Guiyang, Guizhou
Study site
Hengshui, Hebei
Study site
Nanchang, Jiangxi
Study site
Nanjing, Jiangsu
Study site
Nanning, Guangxi
Study site
Shanghai
Study site
Shenyang, Liaoning
Study site
Shijiazhuang, Hebei
Study site
Shiyan, Hubei
Study site
Suzhou, Jiangsu
Study site
Tianjin
Study site
Wenzhou, Zhejiang
Study site
Wuhan, Hubei
Study site
Xi’an, Shanxi
Study site
Xiamen, Fujian
Study site
Yueyang, Hunan
Malaysia12 sites
Study site
Alor Star, Kedah
Study site
Alor Star, Kedah Darul Aman
Study site
Bagan Serai, Perak
Study site
Ipoh, Perak
Study site
Johor Bahru, Johor
Study site
Kampung Baharu Nilai, Negeri Sembilan
Study site
Kubang Kerian, Kelantan
Study site
Petaling Jaya, Selangor
Study site
Putrajaya, Kuala Lumpur
Study site
Seremban, Negeri Sembilan
Study site
Shah Alam, Selangor
Study site
Tampin, Negeri Sembilan
South Korea5 sites
Study site
Busan
Study site
Goyang-si, Gyeonggi-do
Study site
Seongnam-si, Gyeonggi-do
Study site
Seoul
Study site
Suwon, Gyeonggi-do
Taiwan4 sites
Study site
Kaohsiung City
Study site
New Taipei City
Study site
Taichung
Study site
Taipei
About this study
Official title: 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
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).
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- Alogliptin, Metformin HCl, Alogliptin and Metformin Fixed-Dose Combination (FDC), Alogliptin Placebo, Metformin Placebo
- Keywords
- Drug therapy
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlogliptinDrug
Also called SYR-322; Nesina
Alogliptin tablets
Metformin HClDrug
Also called Glucophage
Metformin HCl capsules
Alogliptin and Metformin Fixed-Dose Combination (FDC)Drug
Also called Kazano
Alogliptin and metformin FDC tablets
Alogliptin PlaceboDrug
Alogliptin placebo-matching tablets
Metformin PlaceboDrug
Metformin placebo-matching capsules
Alogliptin and Metformin FDC PlaceboDrug
Alogliptin and metformin FDC placebo-matching tablets
| Study group | Role | What they receive |
|---|---|---|
| Metformin HCl 500 mg | Active comparator | 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. Receives: Drug: Metformin HCl; Drug: Alogliptin Placebo; Drug: Alogliptin and Metformin FDC Placebo |
| Alogliptin 12.5 mg | Active comparator | 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. Receives: Drug: Alogliptin; Drug: Metformin Placebo; Drug: Alogliptin and Metformin FDC Placebo |
| Alogliptin 12.5 mg + Metformin HCl 500 mg FDC | Experimental | 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. Receives: Drug: Alogliptin and Metformin Fixed-Dose Combination (FDC); Drug: Alogliptin Placebo; Drug: Metformin Placebo |
| Placebo | Placebo comparator | 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. Receives: Drug: Alogliptin Placebo; Drug: Metformin Placebo; Drug: Alogliptin and Metformin FDC Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 (or Early Termination)
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.
Measured: Baseline and Week 26 (or Early termination)
Secondary outcomes (13)
Change From Baseline in HbA1c at Weeks 4, 8, 12, 16 and 20
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.
Measured: Baseline and Weeks 4, 8, 12, 16 and 20
Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 8, 12, 16, 20 and 26
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.
Measured: Baseline and Weeks 4, 8, 12, 16, 20 and 26
Time to Hyperglycemic Rescue Event
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.
Measured: From the date of randomization through Week 26
Percentage of Participants Requiring Hyperglycemic Rescue
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.
Measured: Baseline up to Week 26
Percentage of Participants With Marked Hyperglycemia
Marked hyperglycemia is defined as FPG level ≥200 mg/dL (11.1 mmol/L).
Measured: Baseline up to Week 26
Change From Baseline in Body Weight at Weeks 12 and 26
Change in participant's body weight at Weeks 12 and 26 relative to baseline.
Measured: Baseline and Weeks 12 and 26
Percentage of Participants With Glycosylated Hemoglobin ≤6.5%
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%.
Measured: Week 26
Percentage of Participants With Glycosylated Hemoglobin ≤7.0%
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%.
Measured: Week 26
Percentage of Participants With Glycosylated Hemoglobin ≤7.5%
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%.
Measured: Week 26
Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥0.5%
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%.
Measured: Baseline and Week 26
Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥1.0%
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%.
Measured: Baseline and Week 26
Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥1.5%
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%.
Measured: Baseline and Week 26
Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥2.0%
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%.
Measured: Baseline and Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 647 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890122
- Sponsor's protocol ID
- SYR-322MET_303
- Other IDs
- U1111-1139-0497, NMRR-12-799-12754, CTR20130254, 1036022140
- Status last verified
- Oct 2016
- First submitted
- 26 Jun 2013
- Last updated
- 28 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01890122
- Acronym / sponsor ID
- SYR-322MET_303
- Conditions
- Diabetes Mellitus
- Keywords
- Drug therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 647 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 1 Jul 2013 (estimated)
- Results
- Posted 28 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Metformin HCl 500 mg | Active comparator | Drug: Metformin HCl, Drug: Alogliptin Placebo, Drug: Alogliptin and Metformin FDC PlaceboMetformin 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. |
| Alogliptin 12.5 mg | Active comparator | Drug: Alogliptin, Drug: Metformin Placebo, Drug: Alogliptin and Metformin FDC PlaceboAlogliptin 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. |
| Alogliptin 12.5 mg + Metformin HCl 500 mg FDC | Experimental | Drug: Alogliptin and Metformin Fixed-Dose Combination (FDC), Drug: Alogliptin Placebo, Drug: Metformin PlaceboAlogliptin 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. |
| Placebo | Placebo comparator | Drug: Alogliptin Placebo, Drug: Metformin Placebo, Drug: Alogliptin and Metformin FDC PlaceboAlogliptin 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlogliptinAlso: SYR-322; NesinaAlogliptin tablets | Drug | Alogliptin 12.5 mg |
| Metformin HClAlso: GlucophageMetformin HCl capsules | Drug | Metformin HCl 500 mg |
| Alogliptin and Metformin Fixed-Dose Combination (FDC)Also: KazanoAlogliptin and metformin FDC tablets | Drug | Alogliptin 12.5 mg + Metformin HCl 500 mg FDC |
| Alogliptin PlaceboAlogliptin placebo-matching tablets | Drug | Alogliptin 12.5 mg + Metformin HCl 500 mg FDC, Metformin HCl 500 mg, Placebo |
| Metformin PlaceboMetformin placebo-matching capsules | Drug | Alogliptin 12.5 mg, Alogliptin 12.5 mg + Metformin HCl 500 mg FDC, Placebo |
| Alogliptin and Metformin FDC PlaceboAlogliptin and metformin FDC placebo-matching tablets | Drug | Alogliptin 12.5 mg, Metformin HCl 500 mg, Placebo |
Primary outcome
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 (or Early Termination)
Time frame: Baseline and Week 26 (or Early termination)
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.
13 secondary outcomes
Change From Baseline in HbA1c at Weeks 4, 8, 12, 16 and 20
Time frame: Baseline and Weeks 4, 8, 12, 16 and 20
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
Time to Hyperglycemic Rescue Event
Time frame: From the date of randomization through Week 26
Percentage of Participants Requiring Hyperglycemic Rescue
Time frame: Baseline up to Week 26
Percentage of Participants With Marked Hyperglycemia
Time frame: Baseline up to Week 26
Change From Baseline in Body Weight at Weeks 12 and 26
Time frame: Baseline and Weeks 12 and 26
Percentage of Participants With Glycosylated Hemoglobin ≤6.5%
Time frame: Week 26
Percentage of Participants With Glycosylated Hemoglobin ≤7.0%
Time frame: Week 26
Percentage of Participants With Glycosylated Hemoglobin ≤7.5%
Time frame: Week 26
Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥0.5%
Time frame: Baseline and Week 26
Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥1.0%
Time frame: Baseline and Week 26
Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥1.5%
Time frame: Baseline and Week 26
Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥2.0%
Time frame: Baseline and Week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The Alogliptin-Metformin Fixed Dose Combination (KAZANO) were approved in the United States (US) on 25 January 2013.Link provided by the sponsor.
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Takeda
45 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alogliptin, Metformin HCl and Alogliptin and Metformin Fixed-Dose Combination (FDC) in people with Diabetes Mellitus, run by Takeda at 45 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in China, Malaysia, South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 (or Early Termination) (time frame: Baseline and Week 26 (or Early termination)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2016.