Toujeo Versus NPH Self-titration Study

NCT03389490 | Completed Phase 4

• 1 other identifier: GLARGL08588
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Glycemic variability

  Standard deviation of glucose from continuous glucose monitoring

  24 weeks

Secondary Outcomes (9)

• Glycemic variability

  24 weeks

• Percentage time in target

  24 weeks

• Glycated haemoglobin

  24 weeks

• Fasting blood glucose

  24 weeks

• Incidence of hypoglycemia

  24 weeks

Study Arms (2)

Active

EXPERIMENTAL

Insulin glargine 300U/ml

Drug: Insulin Glargine 300 UNT/ML

Control

ACTIVE COMPARATOR

Neutral Protamine Hagedorn insulin

Drug: Neutral protamine hagedorn insulin

Interventions

Insulin Glargine 300 UNT/ML DRUG

Self titration of insulin glargine U300

Active

Neutral protamine hagedorn insulin DRUG

Self titration of NPH insulin

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetic suboptimally controlled on their previous antidiabetic treatment
• ≤ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Elaine Chow: lead
• Sanofi: collaborator

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Shatin, Hong Kong

Location

Related Publications (2)

• Ling J, Poon EWM, Yang A, Yeung T, Loo K, Ozaki R, Ma RCW, Luk AOY, Kong APS, Chan JCN, Chow E. Glycemic Variability and Time in Range During Self-titration of Once Daily Insulin Glargine 300 U/ml Versus Neutral Protamine Hagedorn Insulin in Insulin-naive Chinese Type 2 Diabetes Patients. Diabetes Ther. 2021 May;12(5):1399-1413. doi: 10.1007/s13300-021-01046-6. Epub 2021 Mar 18.

  PMID: 33738774 DERIVED

• Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.

  PMID: 33166419 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin, Isophane

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Elaine Chow

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr, Clinical Lecturer

Study Record Dates

• First Submitted: December 26, 2017
• First Posted: January 3, 2018
• Study Start: January 1, 2018
• Primary Completion: December 17, 2019
• Study Completion: May 1, 2020
• Last Updated: August 3, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)