A Study of LY2599506 in Patients With Type 2 Diabetes

Lilly

Status and phase: Terminated; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Placebo; Drug: LY2599506

Study type: Interventional

Funder types: Industry

Identifiers

NCT01024244

12781

I2Q-MC-GMAH (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 78 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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78 participants in 5 patient groups, including a placebo group

0 milligrams (mg) Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

100 mg LY2599506

Experimental group

Description:

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.

Treatment:

Drug: LY2599506

200 mg LY2599506

Experimental group

Description:

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

Treatment:

Drug: LY2599506

400 mg LY2599506

Experimental group

Description:

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

Treatment:

Drug: LY2599506

200 mg LY2599506 once daily

Experimental group

Description:

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).

Treatment:

Drug: LY2599506