Phase 2
Completed N=834
A Study to Evaluate the Efficacy and Safety of MEDI0382 in the Treatment of Overweight and Obese Subjects With Type 2 Diabetes
Source: ClinicalTrials.gov NCT03235050 ↗Enrolled (actual)
834
Serious AEs
10.2%
Results posted
Jul 2020
Primary outcomePrimary: Change in HbA1c — -0.18; -1.01; -1.22; -1.09 percentage — p=<0.001
Summary
This study is designed to evaluate the dose range for MEDI0382 with respect to blood glucose control and weight loss effects, as well as to further explore the safety profile of MEDI0382
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c |
-0.40; -1.06; -1.22; -1.12; -0.44; -0.96 | <0.001 sig |
| PRIMARY Percent Change in Body Weight |
-1.14; -3.23; -3.94; -4.60; -0.84; -3.27 | <0.001 sig |
| SECONDARY Change in HbA1c |
-0.40; -1.06; -1.22; -1.12; -0.44; -0.96 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving an HbA1c Target < 7.0% |
19; 50; 143; 143; 25; 48 | <0.001 sig |
| SECONDARY Percent Change in Body Weight |
-1.14; -3.23; -3.94; -4.60; -0.84; -3.27 | <0.001 sig |
| SECONDARY Absolute Change in Body Weight |
-0.71; -2.66; -3.45; -4.42; -1.20; -3.20 | <0.001 sig |
| SECONDARY Percent Change in Body Weight Versus Active Comparator |
-3.40; -2.70; -3.47; -4.33; -4.12; -3.23 | 0.211 |
| SECONDARY Absolute Change in Body Weight Versus Active Comparator |
-3.25; -2.66; -3.45; -4.42; -3.90; -3.20 | 0.284 |
| SECONDARY Percentage of Participants Achieving Weight Loss of ≥5% and ≥10% |
3; 18; 65; 92; 11; 28 | <0.001 sig |
| SECONDARY Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control |
11; 1; 3; 2; 20; 3 | 0.024 sig |
| SECONDARY Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin) |
2.68; 2.76; 2.77; 2.66; 5.13; 5.18 | — |
| SECONDARY Immunogenicity Endpoint: Overall Antidrug Antibody (ADA) Incidence (Number and Percentage of Positive Partipants) |
1; 1; 0; 0; 3; 55 | — |
| SECONDARY Immunogenicity Endpoint: Median Titer of the Anti-Drug Antibodies (ADA) to MEDI0382 in the Positive Participants |
5.0; 5.0; 0; 0; 5.0; 20.0 | — |
Eligibility Criteria
Inclusion Criteria
- Provision of informed consent
- Male and female subjects aged ≥ 18 years at screening
- Body mass index ≥ 25 kg/m2 at screening
- HbA1c range of 7.0% to 10.5% (inclusive) at screening
- Diagnosed with type-2 diabetes mellitus (T2DM) and treated with metformin (stable dose of ≥1500 mg/day or maximal tolerated dose) for at least 2 months prior to screening. Use of another glucose-lowering medication for up to 2 weeks in the 2 months prior to screening is acceptable
- Women of childbearing potential (WOCBP), not breastfeeding and using appropriate birth control to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of investigational product (IP), with a negative pregnancy test within 72 hours prior to the start of IP
Exclusion Criteria
- History of, or any existing condition that, in the opinion of the Investigator, would interfere with evaluation of the IP, put the subject at risk, influence the subject's ability to participate or affect the interpretation of the results of the study and/or any subject unable or unwilling to follow study procedures
- Any subject who has received another IP as part of a clinical study or a GLP-1 receptor agonist containing preparation within the last 30 days or 5 half lives of the drug (whichever is longer) at the time of screening
- Severe allergy/hypersensitivity to any of the proposed study treatments or excipients
- Symptoms of acutely decompensated blood glucose control, a history of type 1 diabetes mellitus or diabetic ketoacidosis, or if the subject has been treated with daily subcutaneous (SC) insulin for a period longer than 2 weeks within 90 days prior to screening
- Acute or chronic pancreatitis. Subjects with serum triglyceride concentrations above 1000 mg/dL (11 mmol/L) at screening
- Significant inflammatory bowel disease or other severe disease or surgery affecting the upper Gastrointestinal (GI) tract
- Significant hepatic disease
- Impaired renal function defined as estimated glomerular filtration rate (eGFR) ≤30 mL/minute/1.73m2 at screening
- Severely uncontrolled hypertension
- Unstable angina pectoris, myocardial infarction (MI), transient ischaemic attack (TIA), or stroke within 3 months prior to screening
- Severe congestive heart failure
Data sourced from ClinicalTrials.gov (NCT03235050). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.