Toujeo Versus NPH Self-titration Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-05-01

Brief Summary

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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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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Active

Insulin glargine 300U/ml

Group Type EXPERIMENTAL

Insulin Glargine 300 UNT/ML

Intervention Type DRUG

Self titration of insulin glargine U300

Control

Neutral Protamine Hagedorn insulin

Group Type ACTIVE_COMPARATOR

Neutral protamine hagedorn insulin

Intervention Type DRUG

Self titration of NPH insulin

Interventions

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Insulin Glargine 300 UNT/ML

Self titration of insulin glargine U300

Intervention Type DRUG

Neutral protamine hagedorn insulin

Self titration of NPH insulin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No