A Study of LY2599506 in Patients With Type 2 Diabetes

NCT01024244 | Terminated Phase 2 Results

• 2 other identifiers: 12781I2Q-MC-GMAH
• Study Type: interventional
• Target: 78
• Locations: 5 countries
• Sites: 16

Brief Summary

The purpose of this study is to help answer the following questions:

• To test if taking LY2599506 for 12 weeks controls blood sugar better than taking placebo for 12 weeks.
• To evaluate the safety of LY2599506 in participants with diabetes.
• To determine if LY2599506 has the ability to control blood sugar in participants with diabetes.
• To determine how much LY2599506 should be given to participants.
• To determine if LY2599506 has an effect on a participant's weight. The study design consists of 4 study periods: a screening period, a 4-week dose adjustment period, an 8-week treatment period, and a 4-week follow-up period.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 12 Weeks

  Change in HbA1c from baseline following 12 weeks of therapy (HbA1c at week 12 minus HbA1c at baseline). Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.

  Baseline, 12 weeks

Secondary Outcomes (20)

• Change From Baseline in the QT Interval in Electrocardiogram (ECG) at 12 Weeks and 16 Weeks

  Baseline, 12 weeks, 16 weeks

• Change From Baseline in the Homeostasis Model Assessment (HOMA2) Pancreatic Beta Cell Function (%B) at 12 Weeks and 16 Weeks

  Baseline, 12 weeks, 16 weeks

• Change From Baseline in the Homeostasis Model Assessment (HOMA2) of Insulin Sensitivity (%S) at 12 Weeks and 16 Weeks

  Baseline, 12 weeks, 16 weeks

• Change From Baseline in Triglycerides, Low-density Lipoprotein Cholesterol (LDL-C), High-density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, Total Cholesterol, and Free Fatty Acids at 12 Weeks and 16 Weeks

  Baseline, 12 weeks, 16 weeks

• Change From Baseline in the European Quality of Life -5 Dimension (EQ-5D) at 12 Weeks and 16 Weeks

  Baseline, 12 weeks, 16 weeks

Study Arms (5)

0 milligrams (mg) Placebo

PLACEBO COMPARATOR

Participants received 2 placebo capsules by mouth (po), twice daily (BID), prior to morning and evening meals for 12 weeks.

Drug: Placebo

100 mg LY2599506

EXPERIMENTAL

Participants received 50-mg capsules of LY2599506 po BID (One 50 mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.

Drug: LY2599506

200 mg LY2599506

EXPERIMENTAL

Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.

Drug: LY2599506

400 mg LY2599506

EXPERIMENTAL

Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.

Drug: LY2599506

200 mg LY2599506 once daily

EXPERIMENTAL

Participants received 200-mg of LY2599506 po once daily (QD) (Two 100 mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).

Drug: LY2599506

Interventions

Placebo DRUG

Administered po BID, prior to morning and evening meals for 12 weeks.

0 milligrams (mg) Placebo

LY2599506 DRUG

Administered po for 12 weeks

Also known as: Glucokinase Activator

100 mg LY2599506; 200 mg LY2599506; 200 mg LY2599506 once daily; 400 mg LY2599506

Eligibility Criteria

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

You may qualify if:

• Have type 2 diabetes mellitus prior to entering the trial.
• Are currently being treated with diet and exercise therapy consistent with the local standards of medical care.
• May be treated with diet and exercise alone or in combination with a stable of metformin for at least 3 month before entering the trial.
• Have a hemoglobin A1c value between 7.0% and 10.0 %, inclusive.
• Are women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause. Male patients will be advised to use a reliable method of birth control during the study and until 3 months after the last dose of study medication if their partner is of child-bearing potential.

You may not qualify if:

• Use of insulin or any antidiabetic agent other than metformin during the 3 months prior entering the trial.
• Have a gastrointestinal disease that significantly impacts gastric emptying or motility (for example, severe gastroparesis or pyloric stenosis), in the opinion of the investigator, or have undergone gastric bypass or gastric banding surgery.
• Have had more than 1 episode of severe hypoglycemia within 6 months prior to entry into the study, or are currently diagnosed as having hypoglycemia unawareness.
• Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months.
• Have cardiac autonomic neuropathy (for example, resting tachycardia or orthostatic hypotension), based on clinical signs, symptoms, or appropriate diagnostic testing.
• Have cardiac disease with functional status that is New York Heart Association Class II, III or IV or a history of myocardial infarction, unstable angina, or decompensated congestive heart failure in the past 6 month.
• Have poorly controlled hypertension (that is, mean systolic blood pressure of greater or equal than 160 mm Hg or mean diastolic blood pressure of greater or equal than 100 mm Hg) history of malignant hypertension, evidence of renal artery stenosis and/or evidence of labile blood pressure including symptomatic postural hypotension. Doses of antihypertensive medications must be stable for 30 days before randomization.
• Have fed or fasting state hypertriglyceridemia (defined as \>6.8 millimoles per liter \[mmol/L\], 600 milligrams per deciliter \[mg/dl\]) at screening. If taking lipid-lowering agents, doses of these medications must be stable for 30 days prior to randomization.
• Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or repeated alanine transaminase (ALT) levels \>2.5 times the upper limit of the reference range at screening.
• Have evidence of a significant active, uncontrolled endocrine or autoimmune abnormality, as judged by the Investigator at screening.
• Have an active or untreated malignancy or have been in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
• Have a history of seizure disorder.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (16)

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.

Topeka, Kansas, 66606, United States

Location

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.

Toms River, New Jersey, 08753, United States

Location

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.

Syracuse, New York, 13210, United States

Location

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.

St Leonards, New South Wales, 2065, Australia

Location

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.

Daw Park, South Australia, 5041, Australia

Location

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.

Box Hill, Victoria, 3128, Australia

Location

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.

Manatí, 00674, Puerto Rico

Location

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.

San Juan, 00907, Puerto Rico

Location

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.

Arkhangelsk, 163045, Russia

Location

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.

Moscow, 119435, Russia

Location

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.

Rostov-on-Don, 344022, Russia

Location

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.

Saint Petersburg, 194354, Russia

Location

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.

Alicante, 03114, Spain

Location

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.

Alzira, 46600, Spain

Location

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.

Dos Hermanas, 41014, Spain

Location

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.

Santa Cruz de Tenerife, 38320, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

glucokinase activator compound 50

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Since Study GMAH was terminated after enrolling only 78 participants with just 10 participants completing 12 weeks of treatment with LY2599506, only disposition, demographics, and safety data are reported.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

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

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2009
• First Posted: December 2, 2009
• Study Start: December 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: December 2, 2011
• Results First Posted: October 26, 2011

Record last verified: 2011-11

Locations

RU (4); ES (4); AU (3); PR (2); US (3)