ENDOCRINOLOGY CLINICAL TRIAL: Obese Patients with Type 2 Diabetes

Hello-

The CRO Clinipace has a new study opportunity in Obese Patients with Type 2 Diabetes that I am passing along to you. Unfortunately, they are working under an extremely tight timeline and at this point responses must be submitted to me by noon (EST) on Wednesday, January 8th.  I have requested an extension to this deadline and will update if one is granted. However, I did not want to wait to hear back to share in case we could not get the extension.

Study details are provided in the table below. Interested investigators (Endocrinologists) are asked to complete the attached spreadsheet and return to me.

 

Therapeutic Area

Endocrinology

Phase

II

Enrollment Duration

6 months

Treatment Duration

6 months

Follow-up Duration

1 month

Drug Administration

Orally:  The assigned dose will be orally administered to subjects once a day (30 minutes before breakfast each day) for 24 consecutive weeks.

# of Patients

Total 255 patients

(85 subjects per treatment group, 20% drop out rate, 3 group)

Protocol

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Evaluate the Efficacy and Safety of <Sponsor Compound>  in Subjects with Obese Type 2 Diabetes

Objectives

  • The primary objective is to assess the dose-dependent efficacy of <Sponsor Compound>  for the treatment of subjects with obese type 2 diabetes.
  • The secondary objective is to assess the safety of <Sponsor Compound>  in the treatment of subjects with obese type 2 diabetes

Primary Clinical Endpoint

  • Change in Glycosylated Hemoglobin (HbA1c) from Baseline at Week 24
  • Changes in Body weight from Baseline at Week 24

Inclusion Criteria (partial listing)

  • Male or females, 18 or older
  • Subjects diagnosed with type 2 diabetes mellitus according to the ADA criteria
  • Subjects whose BMI is 30 kg/m2 or above
  • Subjects with normal renal function defined by 24-hour CLCR ≥ 90 ml/min
  • Subjects treated with other hypoglycemic agent(s) for type 2 diabetes mellitus for at least 2 months prior to randomization and who agree to stay on stable doses of anti-diabetes agents during the study.

Exclusion Criteria (partial listing)

  • Subjects who have any significant DM-related end-organ damages
  • Subjects with non-diabetic renal disease, such as gout, tumors, and chronic kidney disease which may cause proteinuria or microalbuminuria.
  • Subjects who have a history of diabetic ketoacidosis or hyperosmolar non-ketotic coma
  • Subjects who have any disease likely to limit life span and/or increase risks of interventions
  • Carotid B-mode ultrasound test results indicating clinically significant stenosis in the common carotid arteries requiring intervention by angioplasty or resection.
  • Cancer treatment in the past 5 years, with the exception of cancers which have been cured, and carry a good prognosis.
  • Infectious disease:  HIV positivity, active tuberculosis, or pneumonia
  • Subjects with uncontrolled hypertension with average systolic blood pressure of ≥ 160 mmHg or diastolic blood pressure ≥ 95 mmHg at Screening and Baseline.
  • Subjects with evidence of clinically significant cardiovascular or cerebrovascular disease
  • Subjects who have or had any of the following conditions related to gastro disease
  • Chronic hepatitis or cirrhosis
  • Episode of alcoholic hepatitis or pancreatitis
  • Inflammatory bowel disease or irritable bowel syndrome.
  • Significant abdominal surgery (e.g., gastrectomy, gastric bypass) in the past 2 months

 

Krissa Caroff, MS

Clinical Trials Facilitator

NAVREF

www.navref.org

(301) 276-0758