A study for patients with Type 2 Diabetes currently taking insulin glargine with or without metformin.
- Conditions
- Diabetes Mellitus, Type 2MedDRA version: 17.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2012-004229-25-GB
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 300
Male or female patients are eligible to be included in the study only if they meet all of the following criteria:
[1] are men or non-pregnant women aged =18 years at screening
[2] have type 2 diabetes (based on the World Health Organization’s [WHO] diagnostic criteria);
[3] have been treated with basal insulin glargine once daily with or without metformin for at least 3 months prior to screening
[4] doses of once daily insulin glargine and metformin (if taken) must be stable during the 3-month period prior to screening. Insulin glargine dose is considered stable when all doses during this period are within the range defined by ±10% of the most commonly used insulin glargine dose during this same period if that dose is =40 IU; if the most commonly used insulin glargine dose is <40 IU, then all doses for that period must be within the ±4 IU range of the most commonly used dose. Doses of metformin are considered stable if all prescribed doses during this period are in the range between the minimum required dose (=1500 mg/day) and the maximum approved dose per the locally-approved label;
[5] have an HbA1c value =7.0% and =10.5% as assessed by the central laboratory at screening;
[6] require further insulin glargine dose increase at randomisation per the TTT algorithm based on the SMPG data collected during the prior week;
[7] have stable weight (±5%) =3 months prior to screening;
[8] have body mass index (BMI) =45 kg/m2 at screening;
[9] are able and willing to administer once weekly randomized therapy;
[10] in the investigator’s opinion, are well motivated, capable, and willing to:
[a] perform fingerstick PG monitoring, including scheduled PG profile with up to 7 measurements in 1 day;
[b] learn how to self-inject treatment as required for this protocol (visually impaired persons who are not able to perform the injections must have the assistance of a sighted individual trained to inject the study drug; persons with physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject the study drug);
[c] maintain a study diary as required for this protocol;
[11] Are females of childbearing potential (a woman will be considered of childbearing potential if she is not surgically sterilized or if she is between menarche and 1-year postmenopausal [2-years postmenopausal if <50 years of age]) who must:
[a] Test negative for pregnancy at screening, based on a serum pregnancy test;
[b] Agree to use a reliable method of birth control (eg, use of oral contraceptives or Norplant®; a reliable barrier method of birth control [diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms with contraceptive foam, intrauterine devices]; partner with vasectomy; or abstinence if consistent with lifestyle) during the study and for 1 month following the last dose of study drug; and
[c] Not be breastfeeding.
[12] Have given written informed consent to participate in this study in accordance with local regulations and the Ethical Review Board (ERB) governing the study site;
[13] Have a sufficient understanding of the primary language of the countr
Patients excluded from study if meet following criteria at screening, or when indicated below for specific criteria, at randomization/baseline, or any time during screening & lead-in periods:
• have type 1 diabetes mellitus
• treated with ANY other antihyperglycemia regimen, other than basal insulin glargine once daily with/without metformin, within 3 months prior to screening or during lead-in period
• per TTT algorithm, do not require insulin glargine dose increase at randomisation based on SMPG data collected during prior week
• history of =1 episode of ketoacidosis or hyperosmolar state/coma
• history of hypoglycemia unawareness within 6 months prior to screening
• treated with drugs promoting weight loss within 3 months prior to screening or during lead in period
• receiving chronic (>14 days) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, intra-articular, or inhaled preparations) or have received such therapy within 4 weeks prior to screening or during lead in period
• had any of following CV conditions within 2 months prior to screening: acute myocardial infarction , New York Heart Association Class III or IV heart failure, or cerebrovascular accident
• have known clinically significant gastric emptying abnormality (eg, severe diabetic gastroparesis or gastric outlet obstruction) or have undergone gastric bypass (bariatric) surgery or restrictive bariatric surgery
• have acute or chronic hepatitis, signs & symptoms of any other liver disease, or alanine aminotransferase (ALT) level >2.5 times upper limit of reference range, determined by central laboratory (patients with nonalcoholic fatty liver disease eligible)
• history of chronic pancreatitis or acute idiopathic pancreatitis, or diagnosed with any type of acute pancreatitis within 3 months prior to screening
• estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2, calculated by Chronic Kidney Disease-Epidemiology (CKD-EPI) equation, as determined by central laboratory; for patients on metformin, have renal disease or renal dysfunction (eg. a serum creatinine =1.5 mg/dL [male] or =1.4 mg/dL [female] or eGFR [CKD-EPI] <60 mL/min/1.73 m2) (metformin SPC, 2008; Glucophage® USPI, 2009)
• have evidence of significant, uncontrolled endocrine abnormality (eg, thyrotoxicosis, adrenal crisis), in opinion of investigator
• any self or family history of type 2A or type 2B multiple endocrine neoplasia (MEN 2A or 2B) in absence of known C-cell hyperplasia (exclusion includes patients with family history of MEN 2A or 2B, whose family history for the syndrome is rearranged during transfection [RET]-negative; only exception for this exclusion will be for patients whose family members with MEN 2A or 2B have known RET mutation & potential patient for study is negative for RET mutation)
• any self or family history of medullary C-cell hyperplasia, focal hyperplasia, or carcinoma (including sporadic, familial, or part of MEN 2A or 2B syndrome)
• serum calcitonin =20 pg/mL, determined by central laboratory
• evidence of significant, active autoimmune abnormality
• any other condition not listed in this section that is contraindication fo
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