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

NCT01253278 | Completed Phase 1

• 2 other identifiers: 13183I4B-FW-GPCB
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Clinically Significant Effects

  Over four weeks

Secondary Outcomes (8)

• Pharmacokinetics of LY2393910, Area Under the Curve (AUC)

  From predose Day 1 up until Day 19

• Change from baseline to day 28 in glucagon

  Baseline, day 28

• Pharmacokinetics of LY2393910, maximum concentration (Cmax)

  From predose Day 1 up until Day 19

• Change from baseline to day 28 in glucose-like peptide 1 (GLP-1)

  Baseline, day 28

• Change from baseline to day 14 in insulin

  baseline, day 14

Study Arms (5)

20 mg LY2393910

EXPERIMENTAL

Drug: LY2393910

60 mg LY2393910

EXPERIMENTAL

Drug: LY2393910

150 mg LY2393910

EXPERIMENTAL

Drug: LY2393910

450 mg LY2393910

EXPERIMENTAL

Drug: LY2393910

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

LY2393910 DRUG

as capsules, administered orally once daily for two weeks

150 mg LY2393910; 20 mg LY2393910; 450 mg LY2393910; 60 mg LY2393910

Placebo DRUG

as capsules, administered orally once daily for two weeks

Placebo

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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, D-41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 1, 2010
• First Posted: December 3, 2010
• Study Start: March 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: June 10, 2011

Record last verified: 2011-06

Locations

DE (1)