Targlut effect in different doses in type 2 diabetes mellitus.

Dose ranging study of Targlut in type 2 diabetes mellitus - Targlut-2

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/058564

Enrollment

Registered

2023-10-12

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

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

Conditions

Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Adults with age 30 years and above (either gender) with a diagnosis of diabetes mellitus (on stable dose for 3 months) satisfying one or more of the American Diabetes Association (ADA) criteria and willing to provide written informed consent

Exclusion criteria

Exclusion criteria: 1. Patients with HbA1c > 10 or blood sugar level > 300 mg/dl 2. Current use of insulin (if administered previously, there should be a gap of at least 3 months) 3. History of stroke. MI or any revascularization procedure within the last 3 months 4. NYHA class III or IV 5. Pregnant and lactating women or planning to become pregnant in the next 12 weeks 6. Current daily use of any supplement containing the herbs in the study supplement 7. Patients with history of thyroid disorder or any other endocrine disorder that can affect blood sugar level or patient participation 8. Drugs that can increase blood sugar level such as corticosteroids 9. Impaired renal function (eGFR 10. Abnormal liver enzymes (more than 2 times the upper limit of normal) 11. Patients diagnosed with malignancy 12. Patients with diagnosis of psychiatric illness or addiction 13. Patients with history of autoimmune disease or immune compromising disease including HIV/AIDS

Design outcomes

Primary

Measure	Time frame
Safety endpoints Safety assessment will include assessing for any adverse events, assessment of vitals, safety laboratory parameters, SMBG and ECG. Tolerance will be assessed by comparing the frequency of adverse events between 3 dosing regimens, time spent below glycemic range (using CGM), proportion of hypoglycemic events. Safety laboratory tests and ECG will be performed at baseline and at end of study visit. Safety laboratory tests will include complete blood count, liver function test and renal function test and urine routine.Timepoint: 8 weeks	—

Measure

Time frame

Safety endpoints Safety assessment will include assessing for any adverse events, assessment of vitals, safety laboratory parameters, SMBG and ECG. Tolerance will be assessed by comparing the frequency of adverse events between 3 dosing regimens, time spent below glycemic range (using CGM), proportion of hypoglycemic events. Safety laboratory tests and ECG will be performed at baseline and at end of study visit. Safety laboratory tests will include complete blood count, liver function test and renal function test and urine routine.Timepoint: 8 weeks

—

Secondary

Measure	Time frame
Change in anthropometric measures (Weight, BMI, Waist hip ratio)Timepoint: Baseline and 8 weeks;Change in blood pressureTimepoint: Baseline and 8 weeks;Change in blood sugar levels (FBS, PPBS)Timepoint: Baseline and 8 weeks;Change in lipid profileTimepoint: Baseline and 8 weeks;Glycemic variability assessed using CGMTimepoint: Baseline and 8 weeks	—

Countries

India

Contacts

Public ContactDr Vikneswaran G

Narayana Institute of Cardiac Sciences

basavaraj.gs.dr@narayanahealth.org9816038562

Outcome results