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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 (ACADEMIC)

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 (ACADEMIC)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800018458
Enrollment
Unknown
Registered
2018-09-20
Start date
2019-01-15
Completion date
Unknown
Last updated
2021-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus

Interventions

Group 1:Alogliptin
Group 2:Acarbose

Sponsors

First Affiliated Hospital of the Fourth Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. T2DM patients (age =18yr) drug naive or treated with metformin monotherapy (=1500 mg/day or individually maximally tolerated dose) for at least 12 weeks with an HbA1c between = 7.5% and = 11.0% at screening; 2. FPG =13.3mmol/L(=240mg/dL) at screening; 3. Patients with documented history of CHD or High CV risk; 4. History of CHD, defined as previous myocardial infarction or unstable/stable angina; 5. 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; 6. Already treated with Aspirin or should start Aspirin treatment at physicians discretion.

Exclusion criteria

Exclusion criteria: 1. Diagnosis of type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes; 2. Previous treatment with any DPP-4 inhibitor or GLP-1 receptor agonists within 1 year of screening; 3. Any contraindication of Aspirin, DPP-4i and AGI; 4. Clinically apparent liver disease or moderate /severe renal impairment or end-stage renal disease; 5. Unstable CV disorder including heart failure (NYHA class III or IV), refractory angina, uncontrolled arrhythmias, and severe uncontrolled hypertension (systolic blood pressure =180mmHg, or diastolic blood pressure =105mmHg); 6. Acute coronary syndrome event within 6month before randomization.

Design outcomes

Primary

MeasureTime frame
Change from baseline in HbA1c at the end of study (week 16) between the two groups;Overall GI tolerability for Alogliptin compared with acarbose during the whole treatment period;fasting insulin;Fasting Blood Lipids;—

Secondary

MeasureTime frame
The percentage of patients who target the goal of HbA1c<7%;The percentage of patients who target the goal of HbA1c<7% and with no GI effect;The change from baseline in FPG, 2-h PPG, ß-cell function (HOMA-ß) ,lipids and body weight at Week 16;Occurrence of hypoglycemia events;Other AEs;Adherence and tolerability to the treatment;Blood routine;fasting blood sugar;2hPG;routine urine test;—

Countries

China

Contacts

Public ContactYao Zhao
Yao.Zhao@sanofi.com+86 20 89212724

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026