Comparison of hydroxychloroquine 400 mg daily versus teneligliptin 20 mg once daily using continuous glucose monitoring (CGM) on patients uncontrolled on insulin plus oral therapy: pilot study.

Comparison of hydroxychloroquine 400 mg daily versus teneligliptin 20 mg once daily using continuous glucose monitoring (CGM) on patients uncontrolled on insulin therapy: pilot study.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/09/015798

Enrollment

Registered

2018-09-24

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Hydroxychloroquine 400 mg: Oral therapy, once daily at diner for 12 week Intervention2: Teneligliptin 20 mg: Oral therapy, once daily at diner for 12 weeks

Eligibility

Inclusion criteria

Inclusion criteria: Type 2 diabetic patients who were treated with insulin regimen; Ages eligible for study: 18 years to 70 years; HbA1c ranging from 7.5%-10.5% when screening and randomizing; Body mass index ranging from 25 to 35 kg/m2. > 60 Kg body weight.

Exclusion criteria

Exclusion criteria: Type 1 diabetes, Severe complications of diabetes, Any type of diabetic retinopathy and maculopathy or eye abnormalities. Severe renal and liver dysfunction, Severe infections, Pregnant or nursing women and those who might be pregnant, • Alcoholism, • Any patients whom the investigators judged to be inappropriate for this study.

Design outcomes

Primary

Measure	Time frame
1) Mean (Â± standard deviation) 24-hour blood glucose level, 2) mean amplitude of glycemic excursions (MAGE), 3) Fasting blood glucose level, 4) Highest postprandial blood glucose level and time, 5) increase in blood glucose level after each meal, 6) Area under the curve (AUC) for blood glucose level â?¥ 180 mg/dL within 3 hours after each meal, 7) Area over the curve (AOC) for daily blood glucose level 70 mg/dL. Timepoint: 1) Mean (Â± standard deviation) 24-hour blood glucose level, 2) mean amplitude of glycemic excursions (MAGE), 3) Fasting blood glucose level, 4) Highest postprandial blood glucose level and time, 5) increase in blood glucose level after each meal, 6) Area under the curve (AUC) for blood glucose level â?¥ 180 mg/dL within 3 hours after each meal, 7) Area over the curve (AOC) for daily blood glucose level 70 mg/dL.	—

Measure

Time frame

1) Mean (Â± standard deviation) 24-hour blood glucose level, 2) mean amplitude of glycemic excursions (MAGE), 3) Fasting blood glucose level, 4) Highest postprandial blood glucose level and time, 5) increase in blood glucose level after each meal, 6) Area under the curve (AUC) for blood glucose level â?¥ 180 mg/dL within 3 hours after each meal, 7) Area over the curve (AOC) for daily blood glucose level 70 mg/dL. Timepoint: 1) Mean (Â± standard deviation) 24-hour blood glucose level, 2) mean amplitude of glycemic excursions (MAGE), 3) Fasting blood glucose level, 4) Highest postprandial blood glucose level and time, 5) increase in blood glucose level after each meal, 6) Area under the curve (AUC) for blood glucose level â?¥ 180 mg/dL within 3 hours after each meal, 7) Area over the curve (AOC) for daily blood glucose level 70 mg/dL.

—

Secondary

Measure	Time frame
Changes in HbA1c between two groupsChanges in FPG & PPBG between two groupsChanges in body weight at the end between two groups Frequency of hypoglycemia at the end in each group Change in Sr. Creatinine. Timepoint: 12 weeks	—

Countries

India

Contacts

Public ContactDr A S Prakash

Dr. Prakash Diabetes speciality Hospital

drasprakash@rediffmail.com9430842668

Outcome results