The PRIME T2D Trial: Prandial-basal Insulin Regimens to Improve MEaltime Glycemia in Type 2 DiabetesComparison of Two Approaches to Basal-Bolus Insulin Therapy in Patients with Type 2 Diabetes and Inadequate Glycemic Control on Oral Therapy: Comparison of Premixed Insulin Lispro Mid Mixture with Separate Basal and Bolus Insulin Injections - IOOX

• Conditions: type 2 diabetes

• Registration Number: EUCTR2006-002519-28-GR
• Lead Sponsor: Eli Lilly and Company Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1Have type 2 diabetes (World Health Organization [WHO] classification, see Protocol Attachment IOOX.2).
2Are at least 30 years old and less than 80 years old.
3Have been receiving oral antihyperglycemic medications (OAMs) without insulin for at least 90 days immediately prior to the study, including at least two of the following OAMs at maximally tolerated doses, AND meet the additional dosing criteria shown:
Metformin: minimum dose of 1500 mg/day
Sulfonylurea: minimum dose of 1/2 the maximum daily dose, according to the local package insert.
Thiazolidinedione (TZD): minimum dose of 30 mg/day pioglitazone or 4 mg/day rosiglitazone
The OAMs also must be used in accordance with the product label and be approved for use with insulin in the patient’s country (Exclusion Criterion [7]). (Note: Combination treatments of the OAMs above are acceptable if they meet the criteria above. For example, Avandamet [rosiglitazone maleate and metformin hydrochloride] would cover the categories of a TZD and metformin.)
4Have a hemoglobin A1c (HbA1c) >=7.5% and <= 12.0% as measured by a central laboratory at Visit 1.
5As determined by the investigator, are capable and willing to do the following:
•use the insulin injection device according to the instructions provided;
•inject insulin while continuing to use the prestudy regimen of OAMs specified in Inclusion Criterion [3];
•perform self monitoring of blood glucose (SMBG);
•use the patient 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 willing to receive regular telephone calls between visits.
[6]Have given written informed consent to participate in this study in accordance with local regulations.
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

7Are taking a TZD dose greater than what is indicated in combination with insulin according to the TZD label in their respective country. (For example, in the US, rosiglitazone dose greater than 4 mg daily or pioglitazone dose greater than 45 mg daily is not currently indicated.) In countries where the combination of a TZD and insulin is contraindicated, patients taking a TZD must have been on a prestudy regimen of three OAMs in Inclusion Criteria [3] and must discontinue the TZD at least 2 weeks before the randomization visit (Visit 2).
8Are taking any other glucose-lowering agents (such as meglitinide, alpha-glucosidase inhibitors, etc.) not mentioned in Inclusion Criterion [3].
9Have taken acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide in the past 6 weeks or for a total of 30 days or more in the last 24 weeks.
10Have a body mass index greater than 40 kg/m2.
11Have had more than one episode of severe hypoglycemia, as defined in the Abbreviations and Definitions section, within 24 weeks prior to entry into the study.
12Are pregnant or intend to become pregnant during the course of the study or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable.
13Are women who are breastfeeding.
14Have cardiac disease with functional status that is Class III or IV (see Protocol Attachment IOOX.3); or, if taking a TZD, have cardiac disease of a less severe functional status, which would contraindicate in their respective country the use of TZD alone or in combination with insulin.
15Have a history of renal transplantation or are currently receiving renal dialysis.
16Have obvious clinical signs or symptoms, or laboratory evidence, of liver disease (alanine transaminase [ALT] or aspartate transaminase [AST] measurements greater than 2 times the upper limit of the reference range, as defined by the local laboratory).
17Are undergoing therapy for a malignancy, other than basal-cell or squamous-cell skin cancer.
18Have known hypersensitivity or allergy to any of the study insulins or excipients of the study insulins.
19Have had a blood transfusion or severe blood loss within 3 months prior to Visit 1 or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia.
20Have received systemic glucocorticoid therapy within the 3 months prior to Visit 1. (Note: Topical preparations, nasal preparations, intra-articular administration, as well as physiologic replacement for Addison’s disease and hypopituitarism are permitted.)
21Have an irregular sleep/wake cycle (for example, patients who sleep during the day and work during the night).
22Have any other condition (including known drug or alcohol abuse or psychiatric disorder) that precludes the patient from following and completing the protocol.
23Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
24Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
25Are Lilly employees.
For patients using metformin:
26Have a serum creatinine concentration that contraindicates use of metformin according to the country-specific metformin product label.
27Have known metabolic or lactic acidosis.
28Have any con

Study & Design

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