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Toujeo Versus NPH Self-titration Study

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ClinicalTrials.gov Identifier: NCT03389490
Recruitment Status : Not yet recruiting
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Elaine Chow, Chinese University of Hong Kong

Brief Summary:
This is a 24 week, multicentre, prospective, randomized, controlled, parallel-designed (1:1) pilot study.The study will compare glycemic variability in patients treated with insulin glargine U300/ml insulin versus conventional (NPH) insulin using a self titration algorithm.50 type 2 diabetes patients who are newly started on insulin will be recruited. They will be randomly allocated to either insulin glargine U300 or NPH insulin for 26 weeks. All subjects will follow a insulin-self titration algorithm. The study will consist of 9 visits over 26 weeks. Blood glucose variability will be collected by CGM for 7 consecutive days at baseline (week -1) and at week 24.Secondary endpoints other than data on glycemic variability, including HbA1c, fasting plasma glucose, inflammatory markers will be measured during three periods (week 0, week 12 and week 24).

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Insulin Glargine 300 UNT/ML Drug: Neutral protamine hagedorn insulin Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study to Describe the Glycaemic Variability of Insulin Glargine 300U/ml Versus NPH (Neutral Protamine Hagedorn) in the Insulin-naïve Type 2 Diabetes Patients Following a Patient-adjusted Insulin Algorithm in Hong Kong
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Active
Insulin glargine 300U/ml
Drug: Insulin Glargine 300 UNT/ML
Self titration of insulin glargine U300
Active Comparator: Control
Neutral Protamine Hagedorn insulin
Drug: Neutral protamine hagedorn insulin
Self titration of NPH insulin



Primary Outcome Measures :
  1. Glycemic variability [ Time Frame: 24 weeks ]
    Standard deviation of glucose from continuous glucose monitoring


Secondary Outcome Measures :
  1. Glycemic variability [ Time Frame: 24 weeks ]
    Mean Amplitude of Glycemic excursions and Means of Daily Differences

  2. Percentage time in target [ Time Frame: 24 weeks ]
    Percentage of time <3.0mmol/L and >10.0mmol/L

  3. Glycated haemoglobin [ Time Frame: 24 weeks ]
    HbA1c

  4. Fasting blood glucose [ Time Frame: 24 weeks ]
    FPG

  5. Incidence of hypoglycemia [ Time Frame: 24 weeks ]
    Overall incidence of hypoglycemia and nocturnal hypoglycemia

  6. Proportion of patients achieving HbA1c <7.0% [ Time Frame: 24 weeks ]
    Proportion of patients achieving HbA1c <7.0% at week 24 without confirmed hypoglycemia

  7. Treatment satisfaction [ Time Frame: 24 weeks ]
    ITSQ questionnaire

  8. Inflammatory markers [ Time Frame: 24 weeks ]
    change in hs C reactive protein

  9. Heart rate variability [ Time Frame: 24 weeks ]
    Change in heart rate variability



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetic suboptimally controlled on their previous antidiabetic treatment

    • 18 ≤ age ≤ 75
    • Stable dose of oral antidiabetic treatment for > 8 weeks
    • The number of OADs that the patients used should be "3" or less
    • HbA1c level > 7.0% and < 10%
    • Fasting plasma glucose > 8mmol/L and <15mmol
    • BMI < 40 kg/m2
    • Patient who is capable and willing to perform regular SMBG
    • Patient who is capable and willing for insulin injection
    • Confirmed written consent
    • Insulin naïve

Exclusion Criteria:

  • Participation in a clinical trial with any investigational drug used with curative intent and within 30 days prior to study entry
  • Patient known to have hypoglycaemia unawareness or recurrent major hypoglycaemia
  • Any product containing prandial insulin
  • Concomitant medication known to interface with glucose metabolism (such as systematic steroids)
  • Change in dose of non-insulin anti-diabetic treatment or initiation of new anti-diabetic medications in the last 8 weeks prior to screening
  • Patients treated with steroid or nonsteroidal anti-inflammatory drugs
  • Patient who had experienced an acute concurrent illness during the 3-month period before the investigation
  • Patient with hepatic disease and end-stage renal disease
  • Patients unable to comply with follow-up visits
  • Pregnant or breastfeeding women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03389490


Contacts
Contact: Elaine Chow 35051549 e.chow@cuhk.edu.hk

Sponsors and Collaborators
Elaine Chow
Sanofi
Investigators
Principal Investigator: Elaine Chow Chinese University of Hong Kong

Responsible Party: Elaine Chow, Dr, Clinical Lecturer, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03389490     History of Changes
Other Study ID Numbers: GLARGL08588
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Isophane insulin, beef
Insulin
Insulin Glargine
Insulin, Isophane
Isophane Insulin, Human
Protamines
Hypoglycemic Agents
Physiological Effects of Drugs
Heparin Antagonists
Molecular Mechanisms of Pharmacological Action
Coagulants