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Completed

NCT Number: NCT03389490

Toujeo Versus NPH Self-titration Study

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).

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Prince of Wales Hospital

Hong Kong, Shatin

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insulin Glargine 300 UNT/ML

Drug

Self titration of insulin glargine U300

Neutral protamine hagedorn insulin

Drug

Self titration of NPH insulin

Primary outcomes

  1. Glycemic variability

    Time frame: 24 weeks

    Standard deviation of glucose from continuous glucose monitoring

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Elaine Chow

Other

Collaborators

  • Sanofi

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jan 3, 2018
Registry last updated
Aug 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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