Insulin In Gestational Diabetes Mellitus - A Randomised Controlled Study

Premixed Insulin Aspart 30 (Biasp 30) Vs Premixed Human Insulin 30 (Bhi 30)In Gestational Diabetes Mellitus ? A Randomised Controlled Study - Premixed Insulin Aspart 30 (Biasp 30) Premixed Human Insulin 30 (Bhi 30)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/091/000093

Enrollment

286

Registered

2011-02-10

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

Health Condition 1: null- Gestational Diabetes Mellitus

Interventions

Intervention1: Premixed Insulin Aspart 30: Initial dose 6 IU follow up throughout pregnancy Control Intervention1: Premixed Human Insulin 30: Initial dose 6 IU follow up throughout pregnancy

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age >= 20 yrs and 2. Gestational weeks ? 12 to 28 weeks 3. 2hr Plasma glucose >= 140 mg/dl with 75g oral glucose tolerance test confirming a diagnosis of GDM 4. BMI (Body mass index) 5. Willing to visit the care provider at least twice a month 6. Must be able to understand the study procedures, choice of treatment provided, risks involved with the study and must voluntarily agree to participate. 7. Must agree to provide permission to obtain all medical records necessary complete data ascertainment during the follow up period. 8. Willing to comply with all study related procedures for the entire study period

Exclusion criteria

Exclusion criteria: 1. Pregnant women with history of pregestational diabetes 2. Pregnant women with a history of type 1 diabetes, a history of ketoacidosis or is currently taking insulin 3. Self&#8208;report of any condition/illness that may affect the study outcomes or would make participation potentially harmful, like severe kidney disease, cardiovascular disease (coronary artery disease, peripheral vascular disease), history of stroke, cancer, severe psychological disorders (schizophrenia, dementia), or hypothyroidism, as ascertained by a detailed medical history. 4. Anemia 5. Pregnant women on antibiotic treatment. 6. Potential Drug allergy.

Design outcomes

Primary

Measure	Time frame
Achievement of fasting (FPG) and postprandial (PPG) glycaemic targets Timepoint: N.A.	—

Secondary

Measure	Time frame
Assessment of birth weight of neonates as well as Maternal and neonatal morbiditiesTimepoint: N.A.	—

Countries

India

Contacts

Public ContactProf V Seshiah

Dr V Seshiah Diabetes Research Institute

vseshiah@gmail.com044-26641414

Outcome results

None listed

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