- To compare efficacy of oral antidiabetics (OAD) combination therapy with either HOE901
insulin analogue once daily or Lispro insulin analogue at mealtime in terms of change in
HbA1c (baseline to endpoint).
- To compare the OAD combination therapy with either HOE901 insulin analogue once daily or
Lispro insulin analogue at mealtime in terms of efficacy and safety.
Inclusion Criteria:
- Subjects with Type 2 Diabetes mellitus for at least 1 year (no history of
ketoacidosis) and treatment with oral antidiabetics (OAD) for at least 6 months prior
to study entry
- Subjects poorly controlled with previous OAD treatment: any mono or combination
therapy approved in combination with insulin according to local SPCs (summary of
product characteristics), not including use of alpha-glucosidase inhibitors, at a
stable dose for least 3 month prior to study entry
- Poor metabolic control with HbA1c (glycosylated hemoglobin) values between 7. 5 % and
10. 5 % and FBG > or = 120 mg/dl (6. 6 mmol/l)
- Body mass index < or = 35 kg/m2
- Ability and willingness of a tight antidiabetic therapy under a stable life-style with
regular meals and to perform blood glucose self monitoring and especially blood
glucose profiles using a blood glucose meter at home, as evidence by daily FBG
measurements and a complete 8-point blood glucose profile obtained over a 24-hour
period
Exclusion Criteria:
- Treatment with any insulin in the last 4 weeks prior to study entry
- Diabetes mellitus following pancreatectomy
- GAD positive (glutamic acid decarboxylase)
- Diabetic retinopathy with surgical treatment (laser photocoagulation or vitrectomy) in
the 3 months prior to study entry or which may require surgical treatment within 3
months of study entry
- Pregnant or breast-feeding
- Women of childbearing potential who did not take adequate contraceptive protection
such as systemic hormones (birth control pills, implant), intrauterine device, or a
barrier method (diaphragm with intravaginal spermicidal, cervical cap, male or female
condom)
- History of hypersensitivity to the study medication or to drugs with similar chemical
structures
- Treatment with any investigational drug in the last 3 months before study entry
- Previous enrollment in a study involving HOE901 insulin analogue
- Likelihood of requiring treatment during the study period with drugs not permitted by
the study protocol (e. g. non-cardio selective beta-blockers, systemic
corticosteroids)
- Clinically relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine,
hematological or other major systemic disease making implementation of the protocol or
interpretation of the study results difficult
- History of drug or alcohol abuse
- Impaired hepatic function, as shown by, but not limited to,alanine aminotransferase
(ALAT) or aspartate aminotransferase (ASAT) above 3x the upper limit of normal, if no
lower values are required by the individually administered OAD
- Impaired renal function, as shown by, but not limited to, serum creatinine > 177
mmol/l (> 2 mg/dl), if no lower values are required by the individually administered
OAD
