Glycaemic Control of Monthly LAPS-Exendin Versus Placebo... | NCT02081118

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

NCT02081118

Sponsor

Hanmi Pharmaceutical Company Limited

Status

Completed

Last Update Posted

Aug 9, 2016Estimated

Enrollment

209Actual

Phase

Phase 2

Conditions

Type 2 Diabetes

Interventions

HM11260C
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

Mar 2015Actual

Completion Date

Apr 2015Actual

First Submitted Date

Feb 24, 2014

First Submission Date that Met QC Criteria

Mar 5, 2014

First Posted Date

Mar 7, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Aug 8, 2016

Certification/Extension First Submitted that Passed QC Review

Aug 8, 2016

Certification/Extension First Posted Date

Aug 9, 2016Estimated

Last Update Submitted Date

Aug 8, 2016

Last Update Posted Date

Aug 9, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

209Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HM11260C (8 mg)	Experimental	Monthly administration of 8 mg of HMC11260C by subcutaneous injection for 16 weeks	Drug: HM11260C
HM11260C (12 mg)	Experimental	Monthly administration of 12 mg of HMC11260C by subcutaneous injection for 16 weeks	Drug: HM11260C
HM11260C (16 mg)	Experimental	Monthly administration of 16 mg of HMC11260C by subcutaneous injection for 16 weeks	Drug: HM11260C
Placebo	Placebo Comparator	Monthly administration of placebo by subcutaneous injection for 16 weeks	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HM11260C	Drug	HM11260C is a novel long-acting form of CA Exendin-4 (an Exendin-4 analogue)	HM11260C (12 mg) HM11260C (16 mg) HM11260C (8 mg)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Fasting plasma glucose levels (FPG)		Up to day 155
7-point glucose profile		Up to day 155
Serum lipid profile

Other Outcomes

Measure	Description	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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

74 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hanmi pharmaceutical		Miami	Florida		United States

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

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Browse Branches

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