A study to compare the effect of double doses of long-acting insulin therapies in patients with type 2 diabetes.

Conditions: Type 2 Diabetes Mellitus
MedDRA version: 17.1Level: LLTClassification code 10049746Term: Insulin-requiring type II diabetes mellitusSystem Organ Class: 100000004861
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2012-005174-56-DE

Lead Sponsor: Eli Lilly and Company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 67

Inclusion Criteria

[1]Have T2DM, based on the World Health Organization (WHO) classification, for =1 year.
[2]Are 18-70 years of age, inclusive.
[3]Use any type of basal insulin (except degludec), including once-or twice-daily human insulin NPH, insulin detemir, or insulin glargine.
[4]Have HbA1c levels =9.0% according to central laboratory testing at Visit 1.
[5]Have BMI =40.0 kg/m2.
[6]Have been treated with stable doses of insulin for at least 30 days before Visit 1 with:
•Basal insulin with daily doses ±30% of mean during the last 4 weeks.
•Doses of a basal insulin must be between 0.3 U/kg/day and 1 unit/kg/day.
[7]If on metformin, TZDs, SGLT-2 inhibitors, or DPP4 inhibitors, must be on stable doses for the last 30 days.
[8]This inclusion criterion applies to all females of child-bearing potential:
•Are not breastfeeding.
•Test negative for pregnancy at Visits 1and 3 based on a serum pregnancy test.
•Intend not to become pregnant during the study.
•Have practiced reliable methods of birth control (for example, use of oral contraceptives or levonorgestrel, diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms with contraceptive foam, intrauterine devices, partner with vasectomy, or abstinence) for at least 6 weeks before screening.
•Agree to continue to use reliable methods of birth control as determined by the investigator during the study (and for 2 weeks following the last dose of study drug).

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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 17

Exclusion Criteria

[14] Are using prandial, self-mixed, or premixed insulin. Patients using prandial
insulin may be switched to daily glargine if investigator judges that the patient
will still meet fasting glucose requirements for randomization.
[15] Are using insulin pump therapy.
[16] Have excessive insulin resistance: Defined as >1.0 U/kg/day as baseline
treatment.
[17] If being treated with SUs before Visit 1, then must have SUs washed out
between Visit 1 and Visit 2.
[18] Use any of these concomitant medications: morphine, codeine, antidiuretics,
glucagon-like peptide-1 (GLP-1) receptor agonists (for example, exenatide,
exenatide once weekly, lixisenatide or liraglutide), or pramlintide, used
concurrently or within 90 days before Visit 1 (screening).
[19] Have hypoglycemia unawareness, defined as confirmed by laboratory test
results or by historical episodes of hypoglycemia <54 mg/dL (3.0 mmol/L)
without symptoms.
[20] Have fasting hypertriglyceridemia >400 mg/dL (>4.5 mmol/L) at Visit 1, as
determined by the local laboratory.
[21] If currently taking prescription or over-the-counter medications to promote
weight loss, should discontinue use of the medication at Visit 1.
[22] Have had any episode of severe hypoglycemia (defined by requiring
assistance due to neurologically disabling hypoglycemia) within 6 months
before entry into the study.
[23] Have had 2 or more emergency room visits or hospitalizations due to poor
glucose control in the past 6 months.
[24] Have had a previous clinically significant episode of ketoacidosis as
determined by the investigator (ketone bodies at fasting and without acidosis
is acceptable) in the past 6 months. If the investigator is in doubt, C-peptide
should be measured, and patients should be excluded if confirmed as Cpeptide
negative (while having a fasting C-peptide in the normal range).
[25] Have 1 of the following concomitant diseases: clinically significant
hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease or
positive for human immunodeficiency virus (HIV), or have signs of active
hepatitis B or C as determined by the investigator, for participation.
[26] Have known history of cardiovascular disease (including angina, transient
ischemic attack [TIA], significant arrhythmia, stroke, myocardial infarction
[MI], or peripheral vascular disease), or history of coronary artery bypass
graft (CABG) or percutaneous coronary interventions (such as coronary
arterial stent insertion or coronary angioplasty).
[27] Have cardiac disease with functional status that is New York Heart
Association Class III or IV (per New York Heart Association Cardiac Disease
Classification) (Attachment 7).
[28] Have history of seizure disorder.
[29] Have history of renal transplantation, are currently receiving renal dialysis, or
have estimated Glomerular Filtration Rate (eGFR) <60 mL/min (Chronic
Kidney Disease Epidemiology Collaboration [CKD-EPI]).
[30] Have any 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 before study entry.
[31] Have obvious clinical signs or symptoms of liver disease (excluding
nonalcoholic fatty liver disease), acute or chronic hepatitis, nonalcoholic
steatohepatitis, or elevated liver enzyme measurements as indicated below:
? total bilirubin 2× the upper limit of normal (ULN) as defined by the local
laboratory, or