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Pilot study to evaluate glycemic control with GlucoTab using an ultra-long acting insulin analogue in non-critically ill patients with type 2 diabetes at the general ward

Phase 4
Conditions
E11
Type 2 diabetes mellitus
Registration Number
DRKS00015119
Lead Sponsor
niv.-Klinik für Innere MedizinKlinische Abteilung für Endokrinologie und Diabetologie
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
30
Inclusion Criteria

Informed consent obtained after being advised of the nature of the study

Male or female aged =18 years

Type 2 diabetes (treated with diet, oral agents, non-insulin injected anti-diabetic medicine, insulin therapy or any combination of the four) or newly diagnosed hyperglycemia which requires s.c. insulin therapy

Exclusion Criteria

Type 1 diabetes, gestational diabetes

Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient

continuous subcutaneous insulin infusion (CSII)

hyperglycaemic episodes (ketoacidosis, hyperosmolar state) if they require intravenous insulin therapy

Pregnancy

Any mental condition rendering the patient incapable of giving his consent

Known or suspected allergy to insulin degludec or insulin aspart

Continuous parenteral nutrition

Participation in another trial which can influence outcome of the trial

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Mean percentage of blood glucose measurements in the target range 70 to 140 mg/dl, as calculated by all premeal and bedtime glucose values measured = 24 hours after start of therapy
Secondary Outcome Measures
NameTimeMethod
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