Toujeo Versus NPH Self-titration Study

Elaine Chow

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Neutral protamine hagedorn insulin; Drug: Insulin Glargine 300 UNT/ML

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03389490

GLARGL08588

Details and patient eligibility

About

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).

Enrollment: 50 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Active

Experimental group

Description:

Insulin glargine 300U/ml

Treatment:

Drug: Insulin Glargine 300 UNT/ML

Control

Active Comparator group

Description:

Neutral Protamine Hagedorn insulin

Treatment:

Drug: Neutral protamine hagedorn insulin