Treatment of the very insulin resistant obese patient with type 2 diabetes

Treatment of the very insulin resistant obese patient with type 2 diabetes. A 24 week prospective randomised open-label treat-to-target exploratory study comparing the GLP-1 analogue exenatide added to Regular insulin U-500 with U-500 alone.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR201308000617367

Enrollment

Registered

2013-08-14

Start date

2011-09-30

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Nutritional, Metabolic, Endocrine Diabetes type 2

Interventions

Exenatide

U-500 Regular Insulin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male or female subjects aged 18-75 years; A history of type 2 diabetes for at least 1 year defined according to the ADA criteria; Total daily insulin requirements of >200 U daily for at least 3 months; HbA1c >7.5 %; Body Mass Index (BMI) >30 kg/m2; Able and willing to understand the protocol and sign informed consent; Able and willing to perform SHGM; Women of childbearing potential must be willing to use adequate contraception for the duration of the study.

Exclusion criteria

Exclusion criteria: Pregnancy or planned pregnancy in women of childbearing potential; Use of any of the excluded medication as outlined above; Any known or suspected underlying endocrinopathy that may be aggravating of causing the insulin resistant state (e.g. Cushings syndrome, acromegaly, glucagonoma etc); Any diagnosed chronic inflammatory or systemic autoimmune disorder which may potentiate the insulin resistant state; Any clinically significant disease or disorder, except for those conditions associated with type 2 diabetes, which in the investigators opinion could interfere with the results of the study; Any patients who, in the opinion of the investigator, are unable to conceptualise and understand the differences between and dosages of U-500 and U-100 insulin; Documented significant CVD (unstable angina, heart failure, coronary artery stenting of bypass surgery in past 6 months); The presence of an active carcinoma or other chronic illness, which may interfere with glycaemic control or potential longevity; Severe renal dysfunction (eGFR <30 ml/min); Unable or unwilling to perform SHGM; History of gastroparesis or other significant upper gastrointestinal pathology.

Design outcomes

Primary

Measure	Time frame
Differences in A1C from baseline (the start of the study) and at 12 and 24 weeks and between groups; Differences in Fasting plasma glucose from baseline (the start of the study) and at 12 and 24 weeks and between groups; Differences at 12 and 24 weeks in 7-point glucose profiles from baseline (the start of the study) and at 12 and 24 weeks and between groups.;A1C; Fasting plasma glucose; 7-point glucose profiles	—

Measure

Time frame

Differences in A1C from baseline (the start of the study) and at 12 and 24 weeks and between groups; Differences in Fasting plasma glucose from baseline (the start of the study) and at 12 and 24 weeks and between groups; Differences at 12 and 24 weeks in 7-point glucose profiles from baseline (the start of the study) and at 12 and 24 weeks and between groups.;A1C; Fasting plasma glucose; 7-point glucose profiles

—

Secondary

Measure	Time frame
Body weight Insulin dose Serum lipid concentrations Hepatic enzymes, SFPT, SGOT, Gamma-GT	—

Countries

South Africa

Contacts

Public ContactLarry A Distiller

Public Enquiries

Larry@cdecentre.co.za27117126000

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026