A Phase 2 Study of LY2605541 Compared with Insulin Glargine in the Treatment of Type 2 Diabetes Mellitus - BIAC
- Conditions
- Diabetes Mellitus, Type 2MedDRA version: 12.0Level: PTClassification code 10053247Term: Insulin-requiring type 2 diabetes mellitus
- Registration Number
- EUCTR2009-014739-19-HU
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 282
[1] Have type 2 diabetes mellitus (T2DM) for at least 1 year based on the World Health Organization (WHO) classification, previous diagnosis, and the investigator’s assessment.
[2] Are =18 years of age.
[3] Have been receiving at least 1 of the following oral antihyperglycemic medications (OAMs) in combination with once daily insulin glargine or once daily NPH for at least 3 months immediately prior to the study. The maximum daily basal insulin dose permitted prior to the study is 1.0 U/kg. Doses of any OAMs are required to have been stable for the 6 weeks prior to Screening visit, and at least 1 of the OAMs must be dosed at or above the dose defined below:
• Metformin, 1500 mg/day
• Sulfonylureas, one half the maximum daily dose according to the local package insert
[4] Have a hemoglobin A1c (HbA1c) value =10.5%, as measured by a central laboratory before Randomization.
[5] Have a BMI =19 and =45 kg/m2.
[6] As determined by the investigator, are capable and willing to do the following:
• Prepare and inject the study insulin with a syringe while continuing to use the prestudy OAMs specified in Inclusion Criterion [3];
• perform self-monitored blood glucose (SMBG);
• complete the study diary as required for this protocol;
• be receptive to diabetes education, including continuing their prestudy diet and activity levels, or following simple dietary advice as appropriate;
• comply with the required study visits and receive telephone calls between visits.
[7] Have access to a telephone.
[8] Be able to read.
[9] Have refrigeration in the home.
[10] Give written informed consent to participate in this study in accordance with local regulations.
[11] Are women of childbearing potential (women not surgically sterilized and between menarche and 2 years postmenopause) who test negative for pregnancy at the time of Screening visit and Randomization based on a urine pregnancy test and agree to use a reliable method of birth control (for example, abstinence from heterosexual intercourse, oral contraceptives, Norplant®, or contraceptive transdermal patch; a reliable barrier method of birth control; intrauterine device; or partner with vasectomy) during the study and until the time they complete the follow-up visit.
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
[12] Have received scheduled, long-term short-acting or rapid-acting or premixed insulin therapy within the past 6 months. Patients who have received short- or rapid-acting insulin as part of short-term insulin therapy (for example, during gestational diabetes, during an acute
hospitalization/illness) or occasional use will be allowed to participate in this study. Occasional use (for example, used to treat acute hyperglycemia) shall be defined as less than daily administration of not more than 1 dose per day of short- or rapid acting insulin.
[13] Have taken any glucose-lowering medications not included in Inclusion Criterion [3] and Exclusion Criterion [12] (for example, acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide) in the 3 months prior to Screening visit.
[14] Are currently taking, or have taken within the 3 months preceding Screening visit, prescription or over-the-counter medications to promote weight loss.
[15] Are currently participating in a weight loss program, or plan to do so during the course of the study.
[16] Have received treatment within the 6 months preceding Screening visit with any antibody-based therapy.
[17] Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intra-articular, intraocular, and inhaled preparations) or have received such therapy within the 4 weeks immediately preceding Screening visit.
[18] 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.
[19] Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months.
[20] Have obvious clinical signs or symptoms, or laboratory evidence, of liver disease (alanine transaminase [ALT], or aspartate transaminase [AST] greater than 2 times the upper limit of normal at Screening visit).
[21] Have a history of renal transplantation, are currently receiving renal dialysis, or have a Screening visit creatinine >2.0 mg/dL (177 µmol/L). (For patients on metformin therapy, see Exclusion Criterion [22].)
[22] For patients using metformin: have a serum creatinine concentration that contraindicates use of metformin according to the country-specific metformin product label; have known metabolic or lactic acidosis; have any condition associated with hypoperfusion, hypoxemia, dehydration, or sepsis; or have had a radiologic contrast study within 48 hours prior to entry in the study or plan to have such a procedure or surgery performed during the study.
[23] Have cardiac disease with functional status that is Class III or IV.
[24] Have electrocardiogram (ECG) abnormalities obtained at Screening visit that, in the opinion of the investigator, are clinically significant with regard to the patient’s participation in the study. These include QTc prolongation (Bazett’s corrected QTc interval, QTcB) of >450 msec in male patients or >470 msec in female patients, or abnormally wide QRS complexes (resulting from bundle branch blocks, intraventricular conduction delays, or pacemakers).
[25] Have a malignancy other than basal cell or squamous cell skin cancer and have not yet been treated, are currently being treated, or were diagnosed less than 5 years ago.
[26] Have fasting triglycerides >500 mg/dL.
[27] Have significant abnormalities (significant would include laboratory deviations requiring acute medical intervention or further medical evalu
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method