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OpenTrials
Completed

NCT Number: NCT03794336

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

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.

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHINA

China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Alogliptin

Drug

Pharmaceutical form: tablet

Route of administration: oral administration

Other names: Nesina

Acarbose

Drug

Pharmaceutical form: tablet

Route of administration: oral administration

Other names: Glucobay

metformin

Drug

Pharmaceutical form: tablet

Route of administration: oral administration

Aspirin

Drug

Pharmaceutical form: tablet

Route of administration: oral administration

Other names: Bayaspirin

Primary outcomes

  1. Change in Hemoglobin A1c

    Time frame: Baseline to week 16

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

  2. Overall Gastrointestinal tolerability

    Time frame: Baseline to week 16

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

Secondary outcomes

  1. Percentage of patients achieving HbA1c <7%

    Time frame: Baseline to Week 16

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

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

    Time frame: Baseline to Week 16

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

  3. Change in Fasting Plasma Glucose (FPG)

    Time frame: Baseline to Week 16

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

  4. Occurrence of hypoglycemia events

    Time frame: Baseline to Week 16

    Number of patients reporting hypoglycemia events

  5. Other Adverse Events (AEs)

    Time frame: Baseline to Week 16

    Number of patients reporting other Adverse Events

  6. Overall tolerability

    Time frame: Baseline to Week 16

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

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

    Time frame: Baseline to Week 16

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

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

    Time frame: Baseline to Week 16

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

  9. Change in Total Cholesterol (TC)

    Time frame: Baseline to Week 16

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

  10. Change in Tri Glycerides (TG)

    Time frame: Baseline to Week 16

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

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

    Time frame: Baseline to Week 16

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

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

    Time frame: Baseline to Week 16

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

  13. Change in body weight

    Time frame: Baseline to Week 16

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

  14. Overall adherence to Investigational Medicinal Product (IMP)

    Time frame: Baseline to Week 16

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

  15. Medication possession ratio (MPR)

    Time frame: Baseline to Week 16

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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Acronym: ACADEMIC

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 7, 2019
Registry last updated
Apr 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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