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Type 2 Diabetes MellitusPhase 4ACADEMICNCT03794336

Efficacy and Safety of Alogliptin vs. Acarbose in Chinese Type 2 Diabetes Mellitus (T2DM) Patients With High CV Risk or CHD Treated With Aspirin and Inadequately Controlled With Metformin Monotherapy or Drug Naive

A Phase 4 study testing Alogliptin, Acarbose and Metformin in people with Type 2 Diabetes Mellitus, run by Sanofi at 1 site in China.

Completed

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

Official record
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Trial summary

Primary Objectives: To assess efficacy in terms of change from baseline in Hemoglobin A1c (HbA1c) at the end of study between the two drugs. To assess tolerability in terms of overall Gastrointestinal (GI) tolerability for Alogliptin compared with acarbose during the whole treatment period. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Alogliptin, Acarbose and Metformin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,293 participants
Where
1 siteChina
Study dates
29 Jun 2019to 14 Dec 2020
Phase
Phase 4
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Type 2 Diabetes Mellitus patients (age ≥18yr) drug naive or treated with metformin monotherapy (≥1500 mg/day or individually maximally tolerated dose) for at least 12 weeks with a Hemoglobin A1c between ≥ 7.5% and ≤ 11.0% at screening.
  • Fasting plasma glucose ≤13.3mmol/L(≤240mg/dL) at screening.
  • Patients with documented history of Coronary Heart Disease (CHD) or High cardiovascular(CV) risk.
  • History of CHD, defined as previous myocardial infarction or unstable/stable angina.
  • High CV risk, defined as male or female (age> 50 yr), combined with at least one of these risk factors as below: family history of cardiovascular disease, history of hypertension, smoking, dyslipidemia, or protein urine.
  • Already treated with Aspirin or should start Aspirin treatment at physician's discretion.

Who cannot join

  • Diagnosis of type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes.
  • Previous treatment with any Dipeptidyl Peptidase -4 inhibitor or glucagon-like peptide-1 (GLP-1) receptor agonists within 1 year of screening;
  • Any contraindication of Aspirin, Dipeptidyl Peptidase- 4 inhibitor and Alpha-glucosidase inhibitor.
  • Clinically apparent liver disease or moderate /severe renal impairment or end-stage renal disease
  • Unstable CV disorder including heart failure (New York Heart Association class III or IV), refractory angina, uncontrolled arrhythmias, and severe uncontrolled hypertension (systolic blood pressure ≥180 mmHg, or diastolic blood pressure ≥105 mmHg).
  • Acute coronary syndrome event within 6 month before randomization
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • CHINA

    China

Other trials in China

About this study

Official title: Efficacy and Safety of Alogliptin vs. Acarbose in Chinese T2DM Patients With High CV Risk or CHD Treated With Aspirin and Inadequately Controlled With Metformin Monotherapy or Drug Naive: A Multicenter, Randomized, Open Label, Prospective Study

Primary Objectives:

  • To assess efficacy in terms of change from baseline in Hemoglobin A1c (HbA1c) at the end of study between the two drugs.
  • To assess tolerability in terms of overall Gastrointestinal (GI) tolerability for Alogliptin compared with acarbose during the whole treatment period.
Read more

Secondary Objectives:

  • To assess efficacy in terms of the percentage of patients achieving HbA1c<7%.
  • To assess efficacy in terms of percentage of patients achieving HbA1c<7% without GI effects.
  • To assess change from baseline in Fasting plasma glucose (FPG), 2-h Post plasma glucose (2-h PPG), β-cell function (HOMA-β), lipids and body weight.
  • To assess safety in terms of occurrence of hypoglycemia events.
  • To assess safety in terms of other adverse events.
  • To assess patient adherence and tolerability.
Read the detailed description

The duration of the study for each patient will be approximately 17 weeks consisting of about 1 week screening period and 16-week treatment period.

Being tested
Alogliptin, Acarbose, Metformin, Aspirin
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

  • AlogliptinDrug

    Also called Nesina

    Pharmaceutical form: tablet

    Route of administration: oral administration

  • AcarboseDrug

    Also called Glucobay

    Pharmaceutical form: tablet

    Route of administration: oral administration

  • MetforminDrug

    Pharmaceutical form: tablet

    Route of administration: oral administration

  • AspirinDrug

    Also called Bayaspirin

    Pharmaceutical form: tablet

    Route of administration: oral administration

Study groups in NCT03794336
Study groupRoleWhat they receive
AlogliptinExperimentalSingle dose of alogliptin once daily for 16 weeks
Receives: Drug: Alogliptin; Drug: Metformin; Drug: Aspirin
AcarboseActive comparatorThrice daily dose of acarbose Dose 1 for 7 days then titrate to thrice daily dose of of acarbose Dose 2
Receives: Drug: Acarbose; Drug: Metformin; Drug: Aspirin

What is being measured

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

  1. Change in Hemoglobin A1c

    Change from baseline in Hemoglobin A1c at the end of study (week 16) between the two drugs

    Measured: Baseline to week 16

  2. Overall Gastrointestinal tolerability

    Incidence of any gastrointestinal adverse events during the whole treatment period.

    Measured: Baseline to week 16

Secondary outcomes (15)

  1. Percentage of patients achieving HbA1c <7%

    Percentage of patients achieving HbA1c <7% at the end of study

    Measured: Baseline to Week 16

  2. Percentage of patients achieving HbA1c <7% without gastrointestinal effects

    Percentage of patients achieving HbA1c <7% without gastrointestinal effects at the end of study

    Measured: Baseline to Week 16

  3. Change in Fasting Plasma Glucose (FPG)

    Change in FPG from baseline to week 16 between the two groups of drugs

    Measured: Baseline to Week 16

  4. Occurrence of hypoglycemia events

    Number of patients reporting hypoglycemia events

    Measured: Baseline to Week 16

  5. Other Adverse Events (AEs)

    Number of patients reporting other Adverse Events

    Measured: Baseline to Week 16

  6. Overall tolerability

    Percentage of patients who discontinued study treatment as a result of adverse drug reaction

    Measured: Baseline to Week 16

  7. Change in Postprandial Plasma Glucose 2-h (PPG)

    Change in PPG from baseline to week 16 between two groups of drug

    Measured: Baseline to Week 16

  8. Change in Homeostasis model assessment-β (HOMA- β)

    Change in HOMA- β from baseline to week 16 between two groups of drug

    Measured: Baseline to Week 16

  9. Change in Total Cholesterol (TC)

    Changes from baseline in TC to week 16 between the two groups

    Measured: Baseline to Week 16

  10. Change in Tri Glycerides (TG)

    Changes from baseline in TG to week 16 between the two groups

    Measured: Baseline to Week 16

  11. Change in High Density Lipoprotein-Cholesterol (HDL-C)

    Changes from baseline in HDL-C to week 16 between the two groups

    Measured: Baseline to Week 16

  12. Change in Low Density Lipoprotein-Cholesterol (LDL-C)

    Changes from baseline in LDL-C to week 16 between the two groups.

    Measured: Baseline to Week 16

  13. Change in body weight

    Changes from baseline in body weight to week 16 between the two groups

    Measured: Baseline to Week 16

  14. Overall adherence to Investigational Medicinal Product (IMP)

    Calculated as overall dosing actually taken IMPs divided by the expected overall dosing as per protocol

    Measured: Baseline to Week 16

  15. Medication possession ratio (MPR)

    Calculated as number of days actually taken IMPs divided by the expected number of days as per protocol

    Measured: Baseline to Week 16

Timeline

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

  1. First posted7 Jan 2019
  2. Study start29 Jun 2019
  3. Primary completion14 Dec 2020
  4. Study completion14 Dec 2020

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,293 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03794336
Sponsor's protocol ID
ALOGLC08867
Other IDs
U1111-1210-0679
Acronym
ACADEMIC
Status last verified
Apr 2022
First submitted
3 Jan 2019
Last updated
25 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Publications

  • Gao B, Gao W, Wan H, Xu F, Zhou R, Zhang X, Ji Q. Efficacy and safety of alogliptin versus acarbose in Chinese type 2 diabetes patients with high cardiovascular risk or coronary heart disease treated with aspirin and inadequately controlled with metformin monotherapy or drug-naive: A multicentre, randomized, open-label, prospective study (ACADEMIC). Diabetes Obes Metab. 2022 Jun;24(6):991-999. doi: 10.1111/dom.14661. Epub 2022 Mar 22.

    PubMed 35112779

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Alogliptin, Acarbose and Metformin in people with Type 2 Diabetes Mellitus, run by Sanofi at 1 site in China.

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 6 inclusion and 7 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 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 in Hemoglobin A1c (time frame: Baseline to week 16). The study lists 2 primary outcomes in all. 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 NCT03794336, 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 25 Apr 2022.

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