Effects of acarbose and acarbose combined with metformin on the microorganisms in the intestinal tract of Indian patients with type 2 diabetes.

Effects of acarbose and combination of acarbose plus metformin on the Gut Microbiota of Indian patients with T2DM

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/10/046514

Enrollment

144

Registered

2022-10-14

Start date

Unknown

Completion date

Unknown

Last updated

2022-11-21

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

Conditions

Health Condition 1: E00-E89- Endocrine, nutritional and metabolic diseases

Interventions

Intervention1: Acarbose: Acarbose 50mg will be given three times daily with meals Control Intervention1: Acarbose plus metformin: FDC of 50 mg acarbose plus 500 mg metformin given three times daily

Eligibility

Inclusion criteria

Inclusion criteria: 1.Newly diagnosed, drug-naÃ¯ve type 2 diabetic patients exhibiting HbA1C >=6.5 â?? 8.0%, eligible either for antidiabetics monotherapy or two drug combination therapy. 2.Female and male patients who are at least 18 years of age 3.Patient or legal delegate signed written informed consent

Exclusion criteria

Exclusion criteria: 1.Patients receiving any anti-diabetic medication at the time of enrollment in the study will be excluded 2.Any contraindication to study drugs as per local prescribing information (list of conditions to be added from prescribing information) 3.Patients with type 1 diabetes 4.Concomitant treatment which influences gut microbiota like prebiotics and probiotics 5.Patients who have hepatic diseases or gastrointestinal tract diseases, psychiatric disorders, neoplasia or any other disease that could interfere with the primary outcomes of the study 6.Patients who have serious infection, pre or post-surgery, or have severe trauma 7.Patients who are pregnant or breast-feeding, or have the potential to become pregnant 8.Patient with history of drug or alcohol abuse within the past 1 year. 9.Institutionalized patients

Design outcomes

Primary

Measure	Time frame
Difference between acarbose monotherapy or acarbose/metformin combination treatment on the modulation in proportion and diversity of gut microbiota as compared to baseline.Timepoint: Baseline and 12 weeks	—

Secondary

Measure	Time frame
Difference between: acarbose monotherapy or acarbose/metformin combination treatment ï?¶ Change from baseline in FPG and 2-hour PPG level at Weeks 12 ï?¶ Change from baseline in inflammatory markers and Weeks 12 ï?¶ Change in CGM profile at baseline and week 12 ï?¶ Change from baseline in BMI at Weeks 12 ï?¶ Change in C-peptide from baseline to Week 12. ï?¶ Change in Insulin level (HOMA -IR & HOMA-B) from baseline to Week 12. ï?¶ Change in lipid profile from baseline to Week 12. Timepoint: 3 months	—

Measure

Time frame

Difference between: acarbose monotherapy or acarbose/metformin combination treatment ï?¶ Change from baseline in FPG and 2-hour PPG level at Weeks 12 ï?¶ Change from baseline in inflammatory markers and Weeks 12 ï?¶ Change in CGM profile at baseline and week 12 ï?¶ Change from baseline in BMI at Weeks 12 ï?¶ Change in C-peptide from baseline to Week 12. ï?¶ Change in Insulin level (HOMA -IR & HOMA-B) from baseline to Week 12. ï?¶ Change in lipid profile from baseline to Week 12. Timepoint: 3 months

—

Countries

India

Contacts

Public ContactDr V Mohan

Madras Diabetes Research Foundation

drmohans@diabetes.ind.in044-43968888

Outcome results

None listed

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