AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 3AM7DNCT01023581

Efficacy and Safety of Alogliptin Plus Metformin in Patients With Type 2 Diabetes

A Phase 3 study testing Alogliptin and Metformin in people with Diabetes Mellitus, Type 2, run by Takeda at 201 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the safety and effectiveness of alogliptin combined with metformin, once daily (QD) or twice daily (BID), in participants with Type 2 Diabetes. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Alogliptin and Metformin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
784 participants
Where
201 sitesin 13 countries
Study dates
Nov 2009to Jun 2011
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has historical diagnosis of Type 2 Diabetes Mellitus.
  • Has been treated with diet and exercise for at least 2 months prior to Screening, and has a Glycosylated Hemoglobin concentration between 7.5% and 10.0%, inclusive at Screening.
  • Has received less than 7 days of any antidiabetic medication within 2 months prior to Screening.
  • Body mass index greater than or equal to 23 kg/m^2 and less than or equal to 45 kg/m^2 (except for Asian or Asian-descendant subjects for whom the range is between 20 and 35 kg/ m^2, inclusive).
  • Fasting C-peptide concentration greater than or equal to 0.8 ng/mL.
  • Regularly using other, non-excluded, medications must be on a stable dose for at least the 4 weeks prior to Screening.
  • Females of childbearing potential and males who are sexually active agree to routinely use adequate contraception from Screening throughout the duration of the study.
  • Able and willing to monitor their own blood glucose concentrations with a home glucose monitor and complete patient diaries.

Who cannot join

  • Hemoglobin less than 12 g/dL for males and less than 10 g/dL for females at Screening Visit.
  • Has a history of any hemoglobinopathy that may affect determination of Glycosylated Hemoglobin.
  • Has a history of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening.
  • Has a history of treatment for diabetic gastric paresis, gastric banding, or gastric bypass surgery.
  • Has a history of diabetic ketoacidosis or hyperosmolar non-ketotic coma.
  • Has systolic blood pressure greater than or equal to 150 mmHg and /or diastolic pressure greater than or equal to 90 mmHg at Screening visit.
Show all 17Show fewer
  • Has New York Heart Association Class III to IV heart failure.
  • Has a history of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within the 90 days prior to Screening.
  • Has Alanine aminotransferase greater than 3 times the upper limit of normal at Screening.
  • Has a history of alcohol or substance abuse with the 2 years prior to Screening.
  • Serum creatinine greater than or equal to 1.5 mg/dL for males and greater than or equal to 1.4 mg/dL for females.
  • Has history of cancer, other than squamous cell or basal cell carcinoma of the skin that has not been in full remission for at least 5 years prior to Screening.
  • Has a history of infection with human immunodeficiency virus, hepatitis B virus or hepatitis C virus.
  • Has any major illness or debility that in the investigator's opinion prohibits the subject from completing the study.
  • Has received any investigational drug within the 90 days prior to Screening.
  • Has a history of hypersensitivity or allergy to alogliptin, other DPP-4 inhibitors, metformin or related compounds.
  • Has used oral or systematically injected glucocorticoids or weight loss drugs prior to 2 months to screening.

Trial locations and contacts

201 sites in 13 countries.

201 sites in 13 countries

United States109 sites

  • Study site

    Altoona, Pennsylvania

  • Study site

    Anaheim, California

  • Study site

    Asheville, North Carolina

  • Study site

    Atlanta, Georgia

  • Study site

    Bensalem, Pennsylvania

  • Study site

    Blue Ridge, Georgia

  • Study site

    Boca Raton, Florida

  • Study site

    Bountiful, Utah

  • Study site

    Bradenton, Florida

  • Study site

    Brentwood, Tennessee

  • Study site

    Brick, New Jersey

  • Study site

    Bristol, Tennessee

  • Study site

    Buena Park, California

  • Study site

    Carrollton, Texas

  • Study site

    Cathedral City, California

  • Study site

    Chandler, Arizona

  • Study site

    Charlotte, North Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    Cleveland, Ohio

  • Study site

    Colorado Springs, Colorado

  • Study site

    Columbia, South Carolina

  • Study site

    Council Bluffs, Iowa

  • Study site

    Crossville, Tennessee

  • Study site

    Cutler Bay, Florida

  • Study site

    Dallas, Texas

  • Study site

    Dearborn, Michigan

  • Study site

    Decatur, Georgia

  • Study site

    Deer Park, Texas

  • Study site

    Dothan, Alabama

  • Study site

    Downingtown, Pennsylvania

  • Study site

    Dubuque, Iowa

  • Study site

    El Paso, Texas

  • Study site

    Elizabeth, New Jersey

  • Study site

    Fargo, North Dakota

  • Study site

    Fleetwood, Pennsylvania

  • Study site

    Flint, Michigan

  • Study site

    Gallipolis, Ohio

  • Study site

    Greensboro, North Carolina

  • Study site

    Greenville, South Carolina

  • Study site

    Hayden Lake, Idaho

  • Study site

    Henderson, Nevada

  • Study site

    Hialeah, Florida

  • Study site

    Houston, Texas

  • Study site

    Hurst, Texas

  • Study site

    Johnson City, Tennessee

  • Study site

    Kalamazoo, Michigan

  • Study site

    Katy, Texas

  • Study site

    La Porte, Indiana

  • Study site

    Las Vegas, Nevada

  • Study site

    Lauderdale Lakes, Florida

  • Study site

    Lawrenceville, Georgia

  • Study site

    Lexington, Kentucky

  • Study site

    Little Rock, Arkansas

  • Study site

    Louisville, Kentucky

  • Study site

    Marrero, Louisiana

  • Study site

    Mason, Ohio

  • Study site

    Maumee, Ohio

  • Study site

    McKenzie, Tennessee

  • Study site

    Melrose Park, Illinois

  • Study site

    Mesa, Arizona

  • Study site

    Miami, Florida

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Mishawaka, Indiana

  • Study site

    Mooresville, North Carolina

  • Study site

    Murrells Inlet, South Carolina

  • Study site

    Muscle Shoals, Alabama

  • Study site

    National City, California

  • Study site

    Norman, Oklahoma

  • Study site

    North Dartmouth, Massachusetts

  • Study site

    North Massapequa, New York

  • Study site

    North Myrtle Beach, South Carolina

  • Study site

    Ocala, Florida

  • Study site

    Odessa, Texas

  • Study site

    Ogden, Utah

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Omaha, Nebraska

  • Study site

    Opa-locka, Florida

  • Study site

    Orlando, Florida

  • Study site

    Oxon Hill, Maryland

  • Study site

    Panama City, Florida

  • Study site

    Pell City, Alabama

  • Study site

    Pembroke Pines, Florida

  • Study site

    Perkasie, Pennsylvania

  • Study site

    Petersburg, Virginia

  • Study site

    Phoenix, Arizona

  • Study site

    Picayune, Mississippi

  • Study site

    Pismo Beach, California

  • Study site

    Roseville, California

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    Santa Ana, California

  • Study site

    Schertz, Texas

  • Study site

    Searcy, Arkansas

  • Study site

    Shippensburg, Pennsylvania

  • Study site

    Sierra Vista, Arizona

  • Study site

    South Burlington, Vermont

  • Study site

    Spring, Texas

  • Study site

    Spring Hill, Tennessee

  • Study site

    St Louis, Missouri

  • Study site

    Sugarland, Texas

  • Study site

    Taylors, South Carolina

  • Study site

    Tempe, Arizona

  • Study site

    Tempe, Arkansas

  • Study site

    Temple, Texas

  • Study site

    Tipton, Pennsylvania

  • Study site

    Topeka, Kansas

  • Study site

    Tulsa, Oklahoma

  • Study site

    Uniontown, Pennsylvania

Other trials in United States

Mexico17 sites

  • Study site

    Acapulco, Guerrero

  • Study site

    Cuernavaca

  • Study site

    Culiacan, Sinoloa

  • Study site

    Distrito Federal

  • Study site

    Durango

  • Study site

    Durango, Durango

  • Study site

    Guadalajara

  • Study site

    Mexico City

  • Study site

    Mexico City, Mexico

  • Study site

    Monclova, Coahuila

  • Study site

    Monterrey

  • Study site

    Monterrey, NL

  • Study site

    Pachuca

  • Study site

    Pachuca, Hidalgo

  • Study site

    Saltillo

  • Study site

    Tijuana, Baja California

  • Study site

    Zapopan, Jalisco

Other trials in Mexico

Ukraine9 sites

  • Study site

    Dnipropetrovsk

  • Study site

    Donetsk

  • Study site

    Ivano-Frankivsk

  • Study site

    Kharkiv

  • Study site

    Kyiv

  • Study site

    Lviv

  • Study site

    Odesa

  • Study site

    Vinnytsia

  • Study site

    Zaporizhzhya

Other trials in Ukraine

Hungary8 sites

  • Study site

    Budaörs

  • Study site

    Debrecen

  • Study site

    Gyöngyös

  • Study site

    Győr

  • Study site

    Gyula

  • Study site

    Komárom

  • Study site

    Szolnok

  • Study site

    Zalaegerszeg

Other trials in Hungary

Poland8 sites

  • Study site

    Bialystok

  • Study site

    Bytom

  • Study site

    Gniewkowo

  • Study site

    Grodzisk Mazowiecki

  • Study site

    Kamieniec Ząbkowicki

  • Study site

    Łęczyca

  • Study site

    Warsaw

  • Study site

    Wroclaw

Other trials in Poland

Puerto Rico8 sites

  • Study site

    Caguas, PR

  • Study site

    Cidra, PR

  • Study site

    Ponce, PR

  • Study site

    Salinas, PR

  • Study site

    San Juan, PR

  • Study site

    San Juan

  • Study site

    Santurce, PR

  • Study site

    Trujillo Alto

Other trials in Puerto Rico

Slovakia8 sites

  • Study site

    Banská Bystrica

  • Study site

    Košice

  • Study site

    Lučenec

  • Study site

    Nitra

  • Study site

    Prešov

  • Study site

    Prievidza

  • Study site

    Šahy

  • Study site

    Žilina

Other trials in Slovakia

Russia7 sites

  • Study site

    Arkhangelsk

  • Study site

    Irkutsk

  • Study site

    Kemerovo

  • Study site

    Moscow

  • Study site

    Perm

  • Study site

    Saint Petersburg

  • Study site

    Ufa

Other trials in Russia

Czechia6 sites

  • Study site

    Hradec Králové

  • Study site

    Olomouc

  • Study site

    Ostrava

  • Study site

    Prague

  • Study site

    Zlín

  • Study site

    Znojmo

Other trials in Czechia

Romania6 sites

  • Study site

    Bacau

  • Study site

    Baia Mare

  • Study site

    Bucharest

  • Study site

    Constanța

  • Study site

    Iași

  • Study site

    Ploieşti

Other trials in Romania

South Africa6 sites

  • Study site

    Cape Town, Western Cape

  • Study site

    Centurion, Gauteng

  • Study site

    Durban, KwaZulu-Natal

  • Study site

    Johannesburg, Gauteng

  • Study site

    Pretoria, Gauteng

  • Study site

    Pretoria

Other trials in South Africa

Israel5 sites

  • Study site

    Haifa

  • Study site

    Holon

  • Study site

    Kfar Saba

  • Study site

    Nahariya

  • Study site

    Safed

Other trials in Israel

Lithuania4 sites

  • Study site

    Kaunas

  • Study site

    Kėdainiai

  • Study site

    Klaipėda

  • Study site

    Vilnius

Other trials in Lithuania

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Alogliptin Plus Metformin, Alogliptin Alone, or Metformin Alone in Subjects With Type 2 Diabetes

The purpose of this study is to evaluate the safety and effectiveness of alogliptin combined with metformin, once daily (QD) or twice daily (BID), in participants with Type 2 Diabetes.

Read the detailed description

There are approximately 19 million people in the United States who have been diagnosed with diabetes mellitus, of which 90% to 95% are type 2. The prevalence of type 2 diabetes varies among racial and ethnic populations and has been shown to correlate with age, obesity, family history, history of gestational diabetes and physical inactivity. Over the next decade, a marked increase in the number of adults with diabetes mellitus is expected.

Metformin is the usual choice of first-line therapy for type 2 diabetes. Metformin targets insulin resistance in type 2 diabetes by inhibiting hepatic glucose production and stimulating glucose uptake in skeletal muscle and adipose tissue, which results in a long-term glucose-lowering effect.

Alogliptin is an inhibitor of the dipeptidyl peptidase IV enzyme. Dipeptidyl peptidase-4 enzyme is thought to be primarily responsible for the in vivo degradation of 2 peptide hormones released in response to nutrient ingestion, namely glucagon-like peptide-1 and glucose-dependent insulinotropic peptide. Both peptides exert important effects on islet beta cells to stimulate glucose-dependent insulin secretion as well as regulating beta cell proliferation and cytoprotection. Glucagon-like peptide-1, but not glucose-dependent insulinotropic peptide, inhibits gastric emptying, glucagon secretion, and food intake. Glucose-dependent insulinotropic peptide has been shown to enhance insulin secretion by direct interaction with a glucose-dependent insulinotropic peptide -specific receptor on islet beta cells. The glucose-lowering actions of glucagon-like peptide-1, but not glucose-dependent insulinotropic peptide, are preserved in patients with type 2 diabetes mellitus. It is expected that inhibition of dipeptidyl peptidase IV will improve glycemic (glucose) control in patients with type 2 diabetes.

Based on the potential, complimentary mechanisms of action of alogliptin and metformin, this study will compare the safety and efficacy of alogliptin and metformin (SYR-322MET) on improving glycemic control in patients with type 2 diabetes mellitus who are inadequately controlled by diet adjustment and exercise alone.

Participants taking part in this study will receive dietary and exercise coaching, and will monitor their own blood glucose concentrations with a home glucose monitor. Participants will also be required to maintain a hypoglycemic diary throughout the course of the study. Participation in this study is expected to last up to 34 weeks.

Being tested
Alogliptin, Metformin, Alogliptin Placebo, Metformin Placebo
Keywords
Type 2 Diabetes mellitus, Non-insulin dependent diabetes mellitus, Drug Therapy, Hypoglycemia,, Hyperglycemia
Medical subject headings
Diabetes Mellitus, Type 2, Hypoglycemia, Hyperglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlogliptinDrug

    Also called SYR-322

    Alogliptin tablets.

  • MetforminDrug

    Also called Glucophage, Glucophage XR, Riomet, Fortamet

    Metformin capsules

  • Alogliptin PlaceboDrug

    Alogliptin placebo-matching tablets.

  • Metformin PlaceboDrug

    Metformin placebo-matching capsules.

Study groups in NCT01023581
Study groupRoleWhat they receive
PlaceboPlacebo comparatorAlogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
Receives: Drug: Alogliptin Placebo; Drug: Metformin Placebo
Alogliptin 25 QDExperimentalAlogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
Receives: Drug: Alogliptin; Drug: Metformin Placebo
Alogliptin 12.5 BIDExperimentalAlogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
Receives: Drug: Alogliptin; Drug: Metformin Placebo
Metformin 500 BIDActive comparatorAlogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
Receives: Drug: Metformin; Drug: Alogliptin Placebo
Metformin 1000 BIDActive comparatorAlogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
Receives: Drug: Metformin; Drug: Alogliptin Placebo
Alogliptin 12.5 BID + Metformin 500 BIDExperimentalAlogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
Receives: Drug: Alogliptin; Drug: Metformin
Alogliptin 12.5 BID + Metformin 1000 BIDExperimentalAlogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
Receives: Drug: Alogliptin; Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26

    The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).

    Measured: Baseline and Week 26.

Secondary outcomes (2)

  1. Change From Baseline in HbA1c Over Time

    The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) was assessed at Weeks 4, 8, 12, 16 and 20.

    Least squares means are from an analysis of covariance (ANCOVA) model with treatment and geographic region as fixed effects, and baseline HbA1c as a covariate.

    Measured: Baseline and Weeks 4, 8, 12, 16, and 20.

  2. Change From Baseline in Fasting Plasma Glucose Over Time

    The change from Baseline in fasting plasma glucose was assessed at Weeks 1, 2, 4, 8, 12, 16, 20 and 26. Least Squares Means were from an ANCOVA model with treatment and geographic region as fixed effects, and baseline fasting plasma glucose as a covariate.

    Measured: Baseline and Weeks 1, 2, 4, 8, 12, 16, 20 and 26.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2009 (estimated)
  2. Study startNov 2009
  3. Primary completionJun 2011
  4. Study completionJun 2011

Resources

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
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
784 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01023581
Sponsor's protocol ID
SYR-322MET_302
Other IDs
2009-012652-24, U1111-1112-1912, DOH-27-0910-3155, CTRI/2010/091/000253, 2009
Acronym
AM7D
Status last verified
Feb 2013
First submitted
1 Dec 2009
Last updated
26 Mar 2013
Data monitoring committee
Yes

Publications

  • Pratley RE, Fleck P, Wilson C. Efficacy and safety of initial combination therapy with alogliptin plus metformin versus either as monotherapy in drug-naive patients with type 2 diabetes: a randomized, double-blind, 6-month study. Diabetes Obes Metab. 2014 Jul;16(7):613-21. doi: 10.1111/dom.12258. Epub 2014 Feb 12.

    PubMed 24400655

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Alogliptin and Metformin in people with Diabetes Mellitus, Type 2, run by Takeda at 201 sites in 13 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 8 inclusion and 17 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 26 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 201 sites in United States, Mexico, Ukraine, Hungary, Poland and 8 more countries. 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 26 Mar 2013). 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 (time frame: Baseline and Week 26.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01023581, which also lists 1 linked publication.

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 26 Mar 2013.

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