Glycaemic Control of Monthly LAPS-Exendin Versus Placebo in Subjects of Type 2 Diabetes

A Phase II, 16-week, Double-blind, Placebo-controlled, Parallel-group, Randomised, Multicentre Trial to Assess Effect on Glycaemic Control of Three Doses of HM11260C in Subjects With Inadequately Controlled Type 2 Diabetes Receiving a Stable Dose of Metformin

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02081118

Enrollment

209

Registered

2014-03-07

Start date

2014-02-28

Completion date

2015-04-30

Last updated

2016-08-09

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

Conditions

Type 2 Diabetes

Brief summary

The purpose of this study is to determine the optimal dose or doses of HM11260C, when administered once a month under the skin, to improve the control of blood sugar levels in patients with early-stage type 2 diabetes mellitus (T2DM).

Interventions

DRUGHM11260C

HM11260C is a novel long-acting form of CA Exendin-4 (an Exendin-4 analogue)

DRUGPlacebo

Placebo for HM11260C

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 74 Years

Healthy volunteers

Inclusion criteria

* Ages eligible for study : 18 years to 74 years * Genders eligible for study : Male and Female * Diagnosed with T2DM * Taking a stable dose of metformin monotherapy * HbA1c levels of between ≥ 7.0% and ≤ 10.0% * Females of childbearing potential who are not pregnant and agree to use a reliable method of birth control * Written informed consent must be obtained

Exclusion criteria

* Pregnant or nursing (lactating) women * Diagnosis of type 1 diabetes mellitus * Uncontrolled diabetes defined as a FPG level of \> 240 mg/dL at screening * A significant change in body weight in the 3 months before screening * Any history of GI intolerance * Personal or family history of medullary thyroid cancer (MTC) or a genetic condition that predisposes to MTC * Known history of acute or chronic pancreatitis * A history of alcohol or drug abuse or drug addiction

Design outcomes

Primary

Measure	Time frame
Change in baseline in glycosylated haemoglobin (HbA1c) at 16 weeks	Up to day 155

Secondary

Measure	Time frame
Fasting plasma glucose levels (FPG)	Up to day 155
7-point glucose profile	Up to day 155
Serum lipid profile	Up to day 155
Body weight	Up to day 155
Glucagon	Up to day 155
Glycated albumin	Up to day 155
Fasting insulin	Up to day 155
C-peptide	Up to day 155

Other

Measure	Time frame
Number of Participants with Adverse Events by HM11260C	Up to day 155
Number of Participants with Immunogenicity by HM11260C	Up to day 155

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026