A 12-Week, Phase 2, Randomized, Double-Blind, Active-Controlled Study of LY2599506 Given as Monotherapy or in Combination with Metformin in Patients with Type 2 Diabetes Mellitus - GMAJ

Phase 1

• Conditions: Type 2 diabetes; MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus

• Registration Number: EUCTR2009-016007-39-DE
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-23
• Study Completion: 2010-06-03
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 193

Inclusion Criteria

[1] Have type 2 diabetes mellitus prior to entering the trial based on the disease diagnostic criteria (WHO) classification.
[2] Are currently being treated with diet and exercise therapy consistent with the local standards of medical care, in the opinion of the Investigator.
[3] Patients may be treated with:
Diet and exercise alone OR Diet and exercise in combination with a stable dose of metformin for at least 3 months before Visit 1 OR Diet and exercise in combination with a stable dose of sulfonylurea for at least 3 months before Visit 1 OR Diet and exercise in combination with stable doses of metformin and sulfonylurea for at least 3 months before Visit 1 and have had diabetes for at least 6 years.
[4] Have an HbA1c value between 7% and 10%, inclusive at Visit 1.
[5] Are men or women between the ages of 18 to 70 years, inclusive.
[6] 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. These requirements do not apply if the patient or his partner has been surgically sterilized.
[7] Have a body mass index between 20 and 40 kg/m2, inclusive at Visit 1.
[8] Have stable weight during the 3 months prior to Visit 1 (weight change not to exceed 5 kg over this period by patient self-report).
[9] Are well motivated, capable, and willing to (in the opinion of the Investigator):
• perform SMBG;
• complete study diary/ies, as required for this protocol;
• be receptive to diabetes education, including continuing their prestudy diet and activity levels, and follow simple dietary advice as appropriate.
[10] Have given written informed consent to participate in this study in accordance with local regulations and the ERB governing the study site.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

[11] Use of insulin or any antidiabetic agent other than metformin or sulfonylurea during the 3 months prior to Visit 1.
[12] Have a gastrointestinal disease that significantly impacts gastric empting or motility (for example, severe gastroparesis or pyloric stenosis) , in the opinion of the Investigator, or have undergone gastric bypass or gastric banding surgery.
[13] 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.
[14] Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months.
[15] Are currently taking or have taken within the last 2 months medications which affect body weight.
[16] Have cardiac autonomic neuropathy (for example, resting tachycardia or orthostatic hypotension), based on clinical signs, symptoms, or appropriate diagnostic testing.
17] Have cardiac disease with functional status that is NYHA Class II, III, or IV or a history of myocardial infarction, unstable angina, or decompensated congestive heart failure in the past 6 months.
[18] Have poorly controlled hypertension (that is, mean systolic blood pressure >160 mm/Hg or mean diastolic blood pressure >100 mm/Hg) confirmed by 2 separate blood pressure measurements at Visit 1, 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.
[19] Have a QTcB (Bazett’s-corrected QT interval) interval greater than 450 msec for men or greater than 470 for women at Visit 1 or any personal history of ventricular tachycardia or unexplained syncope.
[20] Have family history of long QT syndrome or family history of sudden death.
[21] Use prescriptions or over-the-counter medications known to prolong the QT interval.
[22] 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 Visit 1, as determined by the central laboratory. (Patients with alanine aminotransferase [ALT] >2 times the upper limit of normal [ULN] should be evaluated for hepatitis).
[23] Have a serum creatinine >2.0 mg/dL (177 µmol/L) or in patients being treated with metformin, a serum creatinine above (or creatinine clearance below) what is approved in the metformin product labeling in the respective country, or are currently receiving renal dialysis.
[24] Have fed or fasting state hypertriglyceridemia (defined as >6.8 mmol/L, 600 mg/dl) at Visit 1. If taking lipid-lowering agents, doses of these medications must be stable for 30 days prior to randomization.
[25] Have evidence of inadequately treated hypothyroidism or hyperthyroidism based on clinical evaluation and/or an abnormal TSH result and which would confound data interpretation or pose a risk to patient safety. Subjects on a stable dose of thyroid replacement therapy may be eligible if they meet the other criteria.
[26] Have a history of a transplanted organ (except for corneal keratoplasty).
[27] Have evidence of a significant active, uncontrolled endocrine or autoimmune abnormality.
[28] Are receiving chronic (>2 weeks) systemic glucocorticoid therapy (excluding topical or inhaled preparations) or have received such therapy within 4 weeks immediately prior to Visit 2.
[29] Have an activ

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified