The purpose of the multicenter, randomized, open-label, parallel-group study EFC11628 is to compare the efficacy and safety of HOE901-U300 with that of Lantus®, both given once-daily s.c. as part of a basal-bolus insulin regimen in patients with…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Efficacy:
HbA1c [change from baseline to endpoint (week 24)]
Secondary outcome
Main secondary endpoints:
• Incidence of patients (%) with at least one nocturnal hypoglycemia between
start of week 9 and endpoint (month 6), indicated as severe and/or confirmed by
plasma glucose < or = 3.9 mmol/L.
• Change in preinjection plasma glucose from baseline to endpoint (month 6)
• Change in variability of preinjection plasma glucose from baseline to
endpoint (month 6)
Other secondary endpoints:
responder analyses for HbA1c and FPG (fasting plasma glucose), and changes from
baseline to endpoint in FPG, 24-hour mean plasma glucose, variability of plasma
glucose, daily basal insulin dose, daily total insulin dose and free fatty
acids.
Safety/Tolerability:
Safety and tolerability analyses will include hypoglycemia, adverse events,
serious adverse events, physical examination, vital signs,
hematology, serum chemistry (see protocol page 12,13 and 14), lipids, ECG,
anti-insulin antibodies, injection site reactions.
Patient reported outcome (PRO):
Diabetes Treatment Satisfaction Questionnaire (DTSQs), Perceived Hyperglycemia
and Perceived Hypoglycemia.
Background summary
Insulin glargine U100 has been marketed as Lantus for more than 10 years. Its
efficacy and safety are well-known through extensive data collection involving
over 100 000 patients in clinical studies, including randomized, controlled
clinical trials and the results of post-marketing surveillance.
The development of HOE901-U300, a concentrated formulation of insulin glargine,
was initiated based on the observation that daily basal insulin dose
requirements increase, when patients are treated to achieve and maintain
glycemic control, resulting in inconvenient, large volume subcutaneous
injections. HOE901-U300 has the same composition as the current Lantus
formulation 100 U/mL with adjustment of 3-times the amount of active
pharmaceutical ingredient and corresponding Zn content.
Study objective
The purpose of the multicenter, randomized, open-label, parallel-group study
EFC11628 is to compare the efficacy and safety of HOE901-U300 with that of
Lantus®, both given once-daily s.c. as part of a basal-bolus insulin regimen in
patients with type 2 diabetes.
The objective of the pharmacogenetic substudy is to investigate the influence
of DNA differences on how the body responds to and how the body handles Lantus
and the new formulation of insulin glargine HOE901-U300.
Study design
Randomized, open-label, 2-arm parallel-group multicenter trial. Patients will
receive in a 1:1 ratio either HOE901-U300 or Lantus®.
The study will include an up to 2-week screening period, a 24-week efficacy and
safety period and a 12-month safety extension period.
Intervention
One group receives HOE901-U300 as basal insulin and the other group receives
Lantus® (insulin glargine) as basal insulin.
Study burden and risks
The risks are related to the blood sampling and possible side effect of the
study medication. The burden for the patient consists of planned number of
visits and telephone calls needed for this trial. The patients will be asked to
keep the e-diary up to date and to performs self measured bloodglucose
measurements.
From patients who are willing to participate in the pharmacogentic substudy a
separate blood sample will be collected (approximately 6 mL).
If possible, the blood sampling will be performed in conjunction with blood
sampling for the main clinical trial EFC11628.
Kampenringweg 45E
GOUDA 2803 PE
NL
Kampenringweg 45E
GOUDA 2803 PE
NL
Listed location countries
Age
Inclusion criteria
Patients with type 2 diabetes mellitus
Exclusion criteria
- Age <18 years;
- HbA1c < 7.0% or >10% at screening;
- Diabetes other than type 2 diabetes mellitus;
- Less than 1 year on basal plus mealtime insulin and self-monitoring of blood glucose;
- Patients using pre-mix insulins or basal insulins other than insulin glargine or NPH and patients using any non-insulin antihyperglycemic drugs other than metformin in the last 3 months before screening;
- Any contraindication to use of insulin glargine as defined in the national product label;
- Patients using human regular insulin as mealtime insulin in the last 3 months before screening visit;
- Use of an insulin pump in the last 6 months before screening visit;
- Initiation of new glucose-lowering agents and/or weight loss drugs in the last 3 months before
screening visit;
- History or presence of clinical significant macular edema likely to require treatment during the study period;
- Most recent eye examination by an opthalmologist>12 months prior randomization visit
- Pregnant or breast-feeding women or women who intend to become pregnant during the study period.
- Patient who has taken other investigational drugs within 1 month or 5 half-lives, whichever is longer
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-023769-23-NL |
| ClinicalTrials.gov | NCT01499082 |
| CCMO | NL37496.060.11 |