Trial Comparing the Effect of Tirzepatide versus Placebo in Patients with Type 2 Diabetes Inadequately Controlled on Insulin Glargine with or without Metformi

Phase 1

• Conditions: Diabetes Mellitus, Type 2; MedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2019-000860-99-ES
• Lead Sponsor: illy S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-09
• Study Completion: 2021-01-13
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 475

Inclusion Criteria

- T2DM
- Been on stable doses of once-daily basal insulin glargine (>0.25 U/kg/day or >20 U/day) and metformin (if taken) during 3-month period prior to Visit 1
- Have HbA1c =7.0% (53 mmol/mol) to <10.5% (91mmol/mol)
- Require further insulin glargine dose increase at Visit 3 per the TTT algorithm based on the SMBG data collected during the prior week
- Stable weight =3 months prior to Visit 1
- BMI =23 kg/m2
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 342
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 130

Exclusion Criteria

- T1DM
- Have a history of severe hypoglycemia and/or hypoglycemia unawareness within 6 months prior to Visit 1
- Had chronic or acute pancreatitis any time prior to study entry (Visit 1)
- Have history of:
• proliferative diabetic retinopathy, or
• diabetic maculopathy, or
• nonproliferative diabetic retinopathy that requires acute treatment
(a dilated fundoscopic examination performed by an ophthalmologist or optometrist between Visit 2 and Visit 3 is required to confirm eligibility)
- Have a history of ketoacidosis or hyperosmolar state/coma
- Have a known clinically significant gastric emptying abnormality, have undergone or plan to have during the course of the study: gastric bypass or restrictive bariatric surgery or chronically take drugs that directly affect GI motility
- Have had MI, stroke, or hospitalization due to CHF within 2 months prior to Visit 1
- History of CHF Class III-IV
- Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase(ALT) level >3.0 times the upper limit of the reference range
- Have been treated with prescription drugs that promote weight loss within 3 months prior to Visit 1 and/or between Visit 1 and Visit 3
- Have been treated with ANY other antihyperglycemia regimen, other than basal insulin once daily with or without metformin, within the 3 months prior to Visit 1, or between Visits 1 and 3.
- Have an estimated glomerular filtration rate <30 mL/min/1.73 m2, calculated by Chronic Kidney Disease Epidemiology as determined by central laboratory at Visit 1; for patients on metformin, estimated glomerular filtration rate <45 mL/min/1.73 m2 (or lower than the country specific threshold for using the protocol required dose of metformin per local label)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified