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[IP] Aventis research study HMR1964 insulin
Insulin Glulisine. C258H384N64O78S6. [3B-L-Lysine,29B-L-glutamic
acid]insulin (human). CAS-207748-29-6. INN.
04A104B06F48BC420FBCCE?order=13">ClinicalTrials.gov - Linking Patients to
Medical Research: Study Details</A>
The purpose of this study is to compare the safety of HMR 1964 and insulin
aspart when used in external pumps with respect to catheter occlusions, GHb
assessment, insulin doses, blood glucose parameters, hypoglycemic episodes,
unexplained hyperglycemia, adverse events, laboratory data, and vital signs.
Condition Treatment or Intervention Phase
Diabetes, type I Drug: HMR 1964, Insulin glulisine <A
<A HREF="http://www.nlm.nih.gov/medlineplus/">MEDLINEplus</A> related
etes</A>Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel
Assignment, Safety Study
Eligibility Ages Eligible for Study: 18 Years and above , Genders
Eligible for Study: Both Criteria INCLUSION CRITERIASubjects meeting all of
the following criteria will be considered for enrollment into the study:
Men and women above the age of 18.
Women are either not of childbearing potential (surgically sterile, or
postmenopausal for more than 2 years) or are not pregnant and agree to use a
reliable contraceptive measure for the duration of the study. Reliable
contraceptive measures include the follows: systemic contraceptive (oral,
implant, injections), diaphragm with intravaginal spermicide, cervical cap,
intrauterine device, or condom with spermicide.
Type 1 diabetes mellitus as established in the medical history (for the
purpose of this protocol: onset of diabetes under the age of 40 and has
required continuous insulin therapy since diagnosis).
At least 1 year of continuous insulin treatment with at least 6 months of
continuous subcutaneous insulin infusion treatment immediately prior to study
Use of the same type of external insulin pump (MiniMed programmable pump, or
Disetronic pump type H Tron Plus V 100 or D Tron) for at least 3 months prior
to study entry.
HbA1c <8.5% measured at visit 1.
Ability and willingness to perform blood glucose monitoring using the
sponsor-provided blood glucose meter and subject diary at home. Informed
consent must be obtained in writing for all subjects at enrollment into the
study (see Section 12.3).
Subjects presenting with any of the following will not be included in the
Active proliferative diabetic retinopathy, as defined by the application of
focal or panretinal photocoagulation or vitrectomy, in the 6 months prior to
visit 1, or any other unstable (rapidly progressing) retinopathy that may
require surgical treatment (including laser photocoagulation) during the
Diabetes other than type 1 diabetes mellitus.
History of serious ketosis episode requiring hospitalization in the 3
History of abscess at the infusion site in the previous 3 months.
Subjects who have undergone pancreas and or islet cell transplants.
Likelihood of requiring treatment during the study period with drugs not
permitted by the study protocol (see Section 6.2).
Treatment with any investigational drug in the last month before visit 1.
History of seizure disorders.
History of hypersensitivity to insulin or insulin analogues or any other
excipients in the HMR1964 or insulin aspart formulation (see the Global
Investigators Brochure  and the insulin aspart SPC  for a list of
Clinically relevant cardiovascular, hepatic, neurologic, endocrine, active
cancer, or other major systemic disease making implementation of the protocol
or interpretation of the study results difficult or would, in the opinion of
the investigator, preclude the safe participation of the subject in this
History of drug or alcohol abuse.
Impaired hepatic function, as shown by but not limited to ALT or AST greater
than twice the normal upper limit measured at visit 1.
Impaired renal function, as shown by but not limited to serum creatinine >177
micromol/L (>2.0 mg/dL) measured at visit 1.
Pregnancy (as determined by pregnancy blood test at visit 1) or
Night shift workers.
Mental condition rendering the subject unable to understand the nature,
scope, and possible consequences of the study.
Subject unlikely to comply with protocol, e.g. an inability and unwillingness
to participate in adequate training, an uncooperative attitude, inability to
return for follow-up visits, and unlikelihood of completing the study.
Employee of the sponsor or of sponsor representatives.
Subjects who have previously been treated with HMR1964. Expected Total En
rollment: 60 Location and Contact Information France Hospital de
Rangueil, Toulouse, 31403, France; Recruiting Elisabeth Souhami, M.D
33-1-4991-4516 More Information Study ID Numbers HMR1964/3006 Date study
started April 2002 Record last reviewed September 2002 NLM Identifier <A
NCT00046150</A> ClinicalTrials.gov processed this record on 2002-11-14
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