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Clinical Trials/EUCTR2014-000493-19-DE
EUCTR2014-000493-19-DE
Active, not recruiting
Phase 1

A randomized, controlled, prospective trial examining the effectiveness of two insulin titration algorithms of long acting insulin (insulin glargine, Lantus® or insulin detemir, Levemir®) in subjects with Type 2 Diabetes mellitus treated with metformin or DPP4 inhibitors

Diabeteszentrum Bad Lauterberg0 sitesMarch 10, 2014
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ConditionsType 2 Diabetes mellitusMedDRA version: 17.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
DrugsLantusLevemir

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Type 2 Diabetes mellitus
Sponsor
Diabeteszentrum Bad Lauterberg
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 10, 2014
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Diabeteszentrum Bad Lauterberg

Eligibility Criteria

Inclusion Criteria

  • •Type 2 diabetes
  • •Male and female
  • •Insulin naïve or treated with insulin detemir or \-glargine
  • •On a stable regimen of metformin or DPP\-4 inhibitor monotherapy
  • •Fasting plasma glucose: \=160mg/dL
  • •Age: 30 \= age \= 75 years
  • •BMI: 20 \= BMI \= 40 kg•m\-2
  • •Women of childbearing potential with use highly effective” methods of contraception (for example, a state after surgical sterilization, hormonal intrauterine devices (coil), oral hormonal contraceptives, sexual abstinence or a surgically sterilized partner).
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:

Exclusion Criteria

  • •Subjects with type 1 diabetes, maturity onset diabetes of the young (MODY) or secondary forms of diabetes such as due to pancreatitis
  • •Patients who suffered from several severe episodes of hypoglycemia in the past 6 month
  • •Patients with preexisting coronary artery disease and signs of coronary ischemia (symptoms, ECG changes under exercise, pathological stress echocardiogram or myocard scintigram), cerebral artery disease (symptoms of cerebral ischemia, i.e. Z.n.TIA or \>50% stenosis), or proliferative retinopathy
  • •Treatment with any hyperglycaemic medication other than metformin or DPP\-4 inhibitor or long\-acting insulin
  • •Indications of renal impairment (Creatinine clearance \<60 ml/min)
  • •History of diabetic ketoacidosis
  • •Indications of pancreatitis
  • •Indications of liver insufficiency
  • •Patients on systemic corticosteroids
  • •Systolic blood pressure \>180 mmHg

Outcomes

Primary Outcomes

Not specified

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