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

Type 2 Diabetes Mellitus Clinical Trial

— ACADEMIC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03794336
• Other study ID #: ALOGLC08867
• Secondary ID: U1111-1210-0679
• Status: Completed
• Phase: Phase 4
• Start date: June 29, 2019
• Est. completion date: December 14, 2020

Study information

• Verified date: April 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1293
• Est. completion date: December 14, 2020
• Est. primary completion date: December 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Alogliptin
Pharmaceutical form: tablet Route of administration: oral administration
• Acarbose
Pharmaceutical form: tablet Route of administration: oral administration
• Metformin
Pharmaceutical form: tablet Route of administration: oral administration
• Aspirin
Pharmaceutical form: tablet Route of administration: oral administration

Locations

Country	Name	City	State
China	CHINA	China

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

China, 

References & Publications (1)

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 Feb 3. doi: 10.1111/dom.14661. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hemoglobin A1c	Change from baseline in Hemoglobin A1c at the end of study (week 16) between the two drugs	Baseline to week 16
Primary	Overall Gastrointestinal tolerability	Incidence of any gastrointestinal adverse events during the whole treatment period.	Baseline to week 16
Secondary	Percentage of patients achieving HbA1c <7%	Percentage of patients achieving HbA1c <7% at the end of study	Baseline to Week 16
Secondary	Percentage of patients achieving HbA1c <7% without gastrointestinal effects	Percentage of patients achieving HbA1c <7% without gastrointestinal effects at the end of study	Baseline to Week 16
Secondary	Change in Fasting Plasma Glucose (FPG)	Change in FPG from baseline to week 16 between the two groups of drugs	Baseline to Week 16
Secondary	Occurrence of hypoglycemia events	Number of patients reporting hypoglycemia events	Baseline to Week 16
Secondary	Other Adverse Events (AEs)	Number of patients reporting other Adverse Events	Baseline to Week 16
Secondary	Overall tolerability	Percentage of patients who discontinued study treatment as a result of adverse drug reaction	Baseline to Week 16
Secondary	Change in Postprandial Plasma Glucose 2-h (PPG)	Change in PPG from baseline to week 16 between two groups of drug	Baseline to Week 16
Secondary	Change in Homeostasis model assessment-ß (HOMA- ß)	Change in HOMA- ß from baseline to week 16 between two groups of drug	Baseline to Week 16
Secondary	Change in Total Cholesterol (TC)	Changes from baseline in TC to week 16 between the two groups	Baseline to Week 16
Secondary	Change in Tri Glycerides (TG)	Changes from baseline in TG to week 16 between the two groups	Baseline to Week 16
Secondary	Change in High Density Lipoprotein-Cholesterol (HDL-C)	Changes from baseline in HDL-C to week 16 between the two groups	Baseline to Week 16
Secondary	Change in Low Density Lipoprotein-Cholesterol (LDL-C)	Changes from baseline in LDL-C to week 16 between the two groups.	Baseline to Week 16
Secondary	Change in body weight	Changes from baseline in body weight to week 16 between the two groups	Baseline to Week 16
Secondary	Overall adherence to Investigational Medicinal Product (IMP)	Calculated as overall dosing actually taken IMPs divided by the expected overall dosing as per protocol	Baseline to Week 16
Secondary	Medication possession ratio (MPR)	Calculated as number of days actually taken IMPs divided by the expected number of days as per protocol	Baseline to Week 16