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A Multiple-Ascending Dose Study in Type 2 Diabetes Mellitus Patients

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01253278
First received: December 1, 2010
Last updated: June 9, 2011
Last verified: June 2011
History of Changes
  Purpose

The study drug LY2393910 is being evaluated as a possible treatment for diabetes. The primary purpose of a patient's participation in this study is to help answer the following research question(s), and not to provide treatment for diabetes:

  • The safety of LY2393910 and any side effects that might be associated with it following 2 weeks of doses
  • How long it takes the body to absorb and remove LY2393910 following dosing over 2 weeks
  • How daily dosing of LY2393910 affects blood levels of sugar (glucose), insulin and other naturally occurring substances in your body
  • How daily dosing of LY2393910 affects the cells that produce insulin
  • Any differences in the above between LY2393910 taken as daily doses in the morning or in the evening

Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: LY2393910
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of Multiple Escalating Oral Doses of LY2393910 in Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Number of Participants with Clinically Significant Effects [ Time Frame: Over four weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics of LY2393910, Area Under the Curve (AUC) [ Time Frame: From predose Day 1 up until Day 19 ] [ Designated as safety issue: No ]
  • Change from baseline to day 28 in glucagon [ Time Frame: Baseline, day 28 ] [ Designated as safety issue: No ]
  • Pharmacokinetics of LY2393910, maximum concentration (Cmax) [ Time Frame: From predose Day 1 up until Day 19 ] [ Designated as safety issue: No ]
  • Change from baseline to day 28 in glucose-like peptide 1 (GLP-1) [ Time Frame: Baseline, day 28 ] [ Designated as safety issue: No ]
  • Change from baseline to day 14 in insulin [ Time Frame: baseline, day 14 ] [ Designated as safety issue: No ]
  • Change from baseline to day 14 in proinsulin [ Time Frame: baseline, day 14 ] [ Designated as safety issue: No ]
  • Change from baseline to day 28 in glucose [ Time Frame: baseline, day 28 ] [ Designated as safety issue: No ]
  • Change from baseline to day 14 in C-peptide [ Time Frame: baseline, day 14 ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: March 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 20 mg LY2393910 Drug: LY2393910
as capsules, administered orally once daily for two weeks
Experimental: 60 mg LY2393910 Drug: LY2393910
as capsules, administered orally once daily for two weeks
Experimental: 150 mg LY2393910 Drug: LY2393910
as capsules, administered orally once daily for two weeks
Experimental: 450 mg LY2393910 Drug: LY2393910
as capsules, administered orally once daily for two weeks
Placebo Comparator: Placebo Drug: Placebo
as capsules, administered orally once daily for two weeks

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of type 2 diabetes mellitus
  • Must be on a stable treatment regimen (maintained on diet/exercise therapy with or without metformin) for at least 4 weeks prior to study entry
  • Have a glycated haemoglobin (HbA1c) value greater than or equal to 6.5% and less than or equal to 10.0% on a stable treatment regimen
  • Weigh 45.0 kg or more
  • Have a Body Mass Index (BMI) greater than or equal to 18.5 and less than or equal to 40.0 kg/m2
  • Are willing and able to conduct self-blood glucose monitoring tests

Exclusion Criteria:

  • Are currently enrolled in, or discontinued within the last 30 days from a clinical trial involving use of an investigational drug or device other than the study drug used in this study, or are concurrently enrolled in any other type of medical research judged not to be compatible with this study
  • Use of insulin for diabetic control for more than 6 consecutive days within 1 year prior to study entry
  • Use of thiazolidinediones within 3 months, or other oral anti-diabetics (OADs), apart from metformin, within 1 month prior to study entry. Metformin is acceptable for this study
  • Previous myocardial infarction, stroke or transient ischaemic event ('TIA'), or clinically significant coronary events or symptoms within 6 months prior to study entry
  • Subjects who have any evidence of heart insufficiency, hypokalaemia, family history of long-QT-syndrome or are receiving other drugs which extend the QT interval
  • Clinically significant peripheral vascular disease
  • Clinical evidence of active diabetic proliferative retinopathy
  • Known significant autonomic neuropathy
  • Any patient having experienced a keto-acidotic episode requiring hospitalisation in the last 6 months
  • Symptomatic hyperglycemia exhibited by significant osmotic symptoms (polyuria or polydipsia), unanticipated weight loss or dehydration
  • Evidence of hepatitis B and/or positive hepatitis B surface antigen, at screening
  • Subjects who have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females)
  • Subjects who are heavy smokers (> 10 cigarettes, or equivalent, per day) or are unable or unwilling to refrain from nicotine during CRU admissions

Exclusion Criteria for EU Site only --

  • Regular use of known drugs of abuse and/or positive findings on urinary drug screening
  • Evidence of human immunodeficiency virus (HIV) and/or positive HIV antibodies
  • Evidence of hepatitis C and/or positive hepatitis C antibodies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01253278

Locations
Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Neuss, Germany, D-41460
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT01253278     History of Changes
Other Study ID Numbers: 13183, I4B-FW-GPCB
Study First Received: December 1, 2010
Last Updated: June 9, 2011
Health Authority: Singapore: Health Sciences Authority
Singapore: Domain Specific Review Boards
Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013