Working… Menu

Toujeo Versus NPH Self-titration Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03389490
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : July 24, 2019
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

Layout table for study information
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
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 18, 2019
Estimated Study Completion Date : December 18, 2019

Resource links provided by the National Library of Medicine

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 ]

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

  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT03389490

Layout table for location contacts
Contact: Elaine Chow 35051549

Layout table for location information
Hong Kong
Prince of Wales Hospital Recruiting
Hong Kong, Shatin, Hong Kong
Contact: Cherry Chiu         
Principal Investigator: Elaine Chow         
Sub-Investigator: Juliana CN Chan         
Sponsors and Collaborators
Elaine Chow
Layout table for investigator information
Principal Investigator: Elaine Chow Chinese University of Hong Kong

Layout table for additonal information
Responsible Party: Elaine Chow, Dr, Clinical Lecturer, Chinese University of Hong Kong Identifier: NCT03389490     History of Changes
Other Study ID Numbers: GLARGL08588
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin Glargine
Insulin, Isophane
Isophane Insulin, Human
Isophane insulin, beef
Hypoglycemic Agents
Physiological Effects of Drugs
Heparin Antagonists
Molecular Mechanisms of Pharmacological Action