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Type 2 DiabetesNCT06273657

Effects of Medisinstart for Type 2 Diabetes

A study testing Medisinstart in people with Type 2 Diabetes, run by Apokus AS at 22 sites in Norway.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Medisinstart is a counseling service in pharmacies where patients who start taking a new medicine receive two follow-up appointments with a pharmacist. The aim of the service is to promote correct medication use and increase patient adherence. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes
What is being tested?
Medisinstart
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
22 sitesNorway
Study dates
7 Feb 2024to Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Extracted a new drug/active substance (A10A/A10B) for type 2 diabetes
  • Age ≥ 18 years
  • The drugs are administered by the patient/relatives
  • Good command of Norwegian, both written and spoken

Who cannot join

  • Inability to understand and/or complete consent forms, questionnaires and/or other patient-oriented materials
  • Not able to attend physical appointments in the pharmacy
  • Not given written consent to participate in the study
  • Diabetes medication is administered by a healthcare professional
  • Known pregnancy
  • HbA1c is unsuitable as an average measure of blood glucose at baseline
  • Received initiation of medication for type 2 diabetes within the last year
  • Ongoing participation in other studies involving similar interventions to increase adherence and ensure correct medication use

Trial locations and contacts

22 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sara Bremer, PhD contact

21620200

sara@apokus.no

Karine Wabø Ruud, PhD contact

21620200

karine@apokus.no

22 sites in 1 country

Norway22 sites, 21 recruiting

  • Vitusapotek Åfjord

    Åfjord, Trøndelag, 7170

    Recruiting

  • Apotek 1 Andslimoen

    Bardufoss, Troms, 9325

    Recruiting

  • Vitusapotek Paradis

    Bergen, Vestland, 5232

    Recruiting

  • Birkeland apotek

    Birkeland, Agder, 4760

    Recruiting

  • Apotek 1 Brandbu

    Brandbu, Innlandet, 2760

    Recruiting

  • Sykehusapoteket i Drammen

    Drammen, Buskerud, 3004

    Active, not recruiting

  • Vitusapotek Gjøvik

    Gjøvik, Innlandet, 2806

    Recruiting

  • Vitusapotek Gotaasgaarden Jessheim

    Jessheim, Akershus, 2050

    Recruiting

  • Boots apotek Kløfta

    Kløfta, Akershus, 2040

    Recruiting

  • Apotek 1 Veakrossen

    Kopervik, Rogaland, 4276

    Recruiting

  • Apotek 1 Lena

    Lena, Innlandet, 2850

    Recruiting

  • Vitusapotek Nesodden

    Nesoddtangen, Akershus, 1452

    Recruiting

  • Sykehusapoteket Oslo, Ullevål

    Oslo, Oslo, 0455

    Recruiting

  • Sykehusapoteket i Oslo, Aker

    Oslo, Oslo, 0586

    Recruiting

  • Vitusapotek Røa

    Oslo, Oslo, 0751

    Recruiting

  • Boots apotek Linnea

    Øystese, Vestland, 5610

    Recruiting

  • Vitusapotek Mariero

    Stavanger, Rogaland, 4017

    Recruiting

  • Ryfylke apotek

    Stavanger, Rogaland, 4150

    Recruiting

  • Vitusapotek Stryn

    Stryn, Vestland, 6783

    Not yet recruiting

  • Sykehusapoteket i Trondheim

    Trondheim, Trøndelag, 7030

    Recruiting

  • Apotek 1 Solsiden

    Trondheim, Trøndelag, 7042

    Recruiting

  • Vitusapotek Ulefoss

    Ulefoss, Telemark, 3830

    Recruiting

Other trials in Norway

About this study

Medisinstart is a counseling service in pharmacies where patients who start taking a new medicine receive two follow-up appointments with a pharmacist. The aim of the service is to promote correct medication use and increase patient adherence. The effect of Medisinstart has previously been studied among patients starting a new cardiovascular drug. The aim of the project is to map the effects of Medisinstart among patients starting a new medication for type 2 diabetes. Knowledge about the effects of Medisinstart is important in order to maximize the benefits of the service for patients and society. The project is being conducted as a randomized controlled trial among adult patients starting a new medication for type 2 diabetes. The intervention group receives Medisinstart, while the control group only receives prescription dispensing as normal. Data collection includes HbA1c analysis in blood samples and responses to questionnaires. HbA1c is an established measure of glycemic control.

Conditions
Type 2 Diabetes
Being tested
Medisinstart
Keywords
Medication related problems, Adherence, Type 2 diabetes, Pharmacist-led intervention, Consultation, Pharmacy
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MedisinstartOther

    Medisinstart is a counseling service in pharmacies where patients who start taking a new medicine receive two follow-up consultations with a pharmacist.

Study groups in NCT06273657
Study groupRoleWhat they receive
MedisinstartExperimentalNot described
Receives: Other: Medisinstart
ControlNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1c

    Change in HbA1c-level from baseline to 6 months after initiation of a new medication for type 2 diabetes.

    Measured: At baseline and 6 months after initation of the new medication for type 2 diabetes.

  2. HbA1c

    Change in HbA1c-level from baseline to 12 months after initiation of a new medication for type 2 diabetes.

    Measured: At baseline and 12 months after initation of the new medication for type 2 diabetes.

Secondary outcomes (6)

  1. Self-reported adherence

    Adherence will be measured by a Norwegian translation of the MARS-5 questionnaire. The total MARS-5 score can have values from 5-25, with higher scores indicating higher adherence.

    Measured: 6 and 12 months after initiation of the new medication for type 2 diabetes

  2. Self-reported adherence

    Adherence will be measured by a Norwegian translations of the question: "People often miss taking doses of their medicines, for a wide range of reasons. Have you missed any doses of your new medicine the last week?" The question will be answered by yes/no.

    Measured: 6 and 12 months after initiation of the new medication for type 2 diabetes

  3. Frequency of medication-related problems

    Pharmacists will report identified medication-related problems (MRPs) in a structured self-developed electronic questionnaire. The MRP categories in the questionnaire are based on the MRP classification presented by Ruths et al. (Tidsskr Nor Laegeforen. 2007 Nov 29;127(23):3073-6). The different MRP categories will be reported as identified or not identified in the consultations.

    Measured: At the first and second Medisinstart consultations and 12 months after initiation of the new medication for type 2 diabetes

  4. Patients' beliefs about their medicines

    Patients' beliefs about their medicines will be measured by a validated Norwegian translation of the Beliefs about Medicines Questionnaire (BMQ). The BMQ general comprises three subscales, Harm, Overuse and Benefit, and the total score of each subscale ranges from 4 to 20. The BMQ specific comprises two subscales, Concerns and Necessity, and the total score of each subscale ranges from 5 to 25. Higher scores indicate stronger beliefs in the concepts represented by the subscale.

    Measured: At baseline and 6 months after initation of the new medication for type 2 diabetes

  5. Diabetes Self-Management

    Diabetes Self-Management will be measured by a validated Norwegian translation of the Diabetes Self-Management Questionnaire-Revised (DSMQ-R). The scores are summed and transformed into a 1-10 scale for each of the following activities: "eating behavior", "medication use", "glucose monitoring", "physical activity" and "interaction with treating physician/healthcare professional". In addition, a total score is calculated as an overall measure of the patient's diabetes self-management. Values in the upper part of the scale indicate good self-care.

    Measured: 12 months after initiation of the new medication for type 2 diabetes

  6. Diabetes Treatment Satisfaction

    Diabetes Treatment Satisfaction will be measured by a validated Norwegian translation of the Diabetes Treatment Satisfaction Questionnaire (DTSQ). The scores range from 0 to 36 where higher scores indicate greater satisfaction with treatment.

    Measured: At baseline and 6 and 12 months after initiation of the new medication for type 2 diabetes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2024
  2. Study start7 Feb 2024
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06273657
Sponsor's protocol ID
Apokus-002
Status last verified
Oct 2026
First submitted
1 Feb 2024
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Medisinstart in people with Type 2 Diabetes, run by Apokus AS at 22 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sara Bremer, PhD (21620200, sara@apokus.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c (time frame: At baseline and 6 months after initation of the new medication for type 2 diabetes.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06273657.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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