A study to compare a new drug for Type 2 Diabetes to placebo (a placebo looks like the study drug but has no medicine) and to a treatment already available for Type 2 Diabetes.

• Register: EUCTR
• Last refreshed on: 17 January 2022
• Main ID: EUCTR2013-003552-21-RO
• Date of registration: 30/05/2014
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: A study to compare a new drug for Type 2 Diabetes to placebo (a placebo looks like the study drug but has no medicine) and to a treatment already available for Type 2 Diabetes.
• Scientific title: Comparison of the Oxyntomodulin Analog, LY2944876, to Once-Weekly Exenatide and to Placebo in Patients with Type 2 Diabetes.
• Date of first enrolment: 29/07/2014
• Target sample size: 540
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-003552-21
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: yes; Other: no; Number of treatment arms in the trial: 6
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Greece, Mexico, Poland, Romania, Spain, United States

Contacts

• Name: Clinical Trial Registry Office
• Affiliation: Eli Lilly and Company

• Name: Clinical Trial Registry Office
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion criteria

Inclusion criteria:
Men or women aged 18 to 80 years with T2DM. Eligibility criteria include: HbA1c =7.0% and =10.5% at screening and treated with diet and exercise alone or on a stable dose of metformin (=1000 mg/day) for 3 months prior to screening. BMI =23 and =45 kg/m2 at screening.
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 337
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 38

Exclusion criteria:
Patients are excluded from participation if they; are women of child bearing potential; used thiazolidinediones within 3 months prior to screening, or any other drugs for treatment of hyperglycemia (except metformin) within the prior 2 months; have used insulin for diabetic control for more than 6 consecutive days within the prior year; and if they have impaired renal function (serum creatinine >124 µmol/L [1.4 mg/dL] in women, >133 µmol/L [1.5 mg/dL] in men).


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2
MedDRA version: 17.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861

Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Intervention(s)

Product Name: LY2944876
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: oxyntomodulin analogue
Other descriptive name: LY2944876
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Trade Name: BYDUREON
Product Name: BYDUREON
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: EXENATIDE
CAS Number: 141758-74-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Primary end point(s): The primary efficacy endpoint is HbA1c change from baseline to 12 weeks

Main Objective: To demonstrate a dose-response relationship of once-weekly subcutaneous injections of LY2944876 on hemoglobin A1c (HbA1c) change from baseline, and from this dose-response relationship at 12 weeks determine which LY2944876 doses are superior to placebo in patients with T2DM inadequately controlled with diet and exercise alone or treated with a stable dose of metformin.

Timepoint(s) of evaluation of this end point: 12 weeks

Secondary Objective: To determine the effect of LY2944876 versus exenatide ER (and to compare the effect of both vs. placebo) on:
• Mean % body weight change from baseline to 12 and 24 weeks
• Safety and tolerability, including gastrointestinal tolerability, incidence and rate of hypoglycemia, hypersensitivity reactions, and pancreatic safety
• Change from baseline of HbA1c at 24 weeks
• Percentage of patients with 5% or greater body weight loss at 24 weeks
• Change from baseline of fasting blood glucose at 12 and 24 weeks

To evaluate the development of treatment-emergent anti-drug antibodies to LY2944876 or polyethylene glycol.
To assess pharmacokinetics (PK) of LY2944876, its variability and potential patient factors that may influence its PK.
To assess the relationship between LY2944876 dose and/or exposure and efficacy, and safety measures, where applicable.

Secondary Outcome(s)

Secondary end point(s): Secondary efficacy measures include: HbA1c, body weight (mean change from baseline and % of patients with > 5% loss from baseline to endpoint), fasting blood glucose; 7 point SMBG profiles; % of patients requiring rescue therapy, lipids, and other circulating biomarkers.
Safety: Vital signs, labs, ECG monitoring, incidence and duration of nausea, vomiting, and diarrhea, assessment of injection site reactions, hypersensitivity reactions, episodes of hypoglycemia, acute pancreatitis , major adverse cardiovascular events, development of anti-drug antibodies, and TEAEs including SAEs and AEs leading to discontinuation.
Health Outcomes: APPADL and IW-SP questionnaires, which are self-rated questionnaires that provide standardized measures of patients’ perceived current health status.
Pharmacokinetic: Venous blood samples to measure the plasma concentrations of LY2944876 using validated bioanalytical assays.
Pharmacodynamic: Endpoints may include, but are not necessarily limited to, endpoints for efficacy (glucose, HbA1c, weight), tolerability (e.g., nausea and vomiting), safety (e.g., corrected QT (QTc) interval, heart rate), and biomarkers (e.g., insulin, glucagon).

Timepoint(s) of evaluation of this end point: 12 and 24 weeks

Secondary ID(s)

2013-003552-21-GR

I7I-MC-XNAA

Source(s) of Monetary Support

Eli Lilly and Company

Ethics review

Status: Approved
Approval date: 05/05/2014
Contact:

Results

• Results available: Yes
• Date Posted: 04/04/2021
• Date Completed: 25/08/2015
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-003552-21/results